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For Physicians FDA Accepts First Gene Therapy for Huntington's Nov 5, 202611 min read Read the story Spotlight Specific Biologics Raises $35M for ALS Gene Editor Nov 5, 20266 min read Read the story Spotlight StimCardio Closes $30M Series A for AFib Wearable Nov 5, 20266 min read Read the story Guidance & Policy FDA Finalizes Potency Guidance for Cell, Gene Therapies Nov 5, 20265 min read Read the story Drugs & Biologics FDA Tentatively Approves First Generic HIV-Prevention Shot Nov 5, 20265 min read Read the story Devices & Diagnostics FDA Flags ButterflyBVM Resuscitators Over Bellows Holes Nov 5, 20265 min read Read the story For Physicians FDA Moves a Targeted Combo Earlier in Prostate Cancer Nov 2, 20269 min read Read the story Spotlight OrthoPediatrics Wins FDA Clearance for Retrograde Femur Nail Nov 2, 20267 min read Read the story Drugs & Biologics FDA Panel Backs Denial of Pediatric Myopia Drops Nov 2, 20265 min read Read the story Drugs & Biologics MHRA Approves Dojolvi for Long-Chain Fatty-Acid Disorders Nov 2, 20264 min read Read the story For Physicians FDA Narrows Menopause Hormone Therapy's Boxed Warning Nov 1, 20269 min read Read the story Spotlight NRx Pharmaceuticals Secures FDA Nod for Ketamine Drug Nov 1, 20266 min read Read the story Spotlight Element Biosciences Launches CE-Marked AVITI Dx Nov 1, 20266 min read Read the story Spotlight Pharaoh Neuro Wins FDA Breakthrough Tag for CSF Device Nov 1, 20266 min read Read the story Drugs & Biologics EMA Opens Safety Review of Immunoglobulin Batches Nov 1, 20266 min read Read the story Drugs & Biologics FDA Eases Boxed Warning on 3 More Estrogen Patches Nov 1, 20266 min read Read the story Devices & Diagnostics FDA Sets a Class II Path for Spinal-Imaging Devices Nov 1, 20266 min read Read the story For Physicians MHRA Lowers Casgevy's Age Floor to Five; FDA's Is Two Oct 31, 20269 min read Read the story For Physicians FDA Approves Voceryq, a DNA Immunotherapy for RRP Oct 31, 20268 min read Read the story Spotlight Bambusa Therapeutics Prices $168.9M Nasdaq IPO Oct 31, 20268 min read Read the story Spotlight Monebo Clears FDA for Kinetic ECG Software Library Oct 31, 20268 min read Read the story Spotlight X9 Wins Second FDA Nod for Dialysis Needle Guidance Oct 31, 20268 min read Read the story Drugs & Biologics MHRA Extends Casgevy Gene Therapy to Children Aged Five Oct 31, 20266 min read Read the story Drugs & Biologics FDA Clears Inovio's Voceryq for Airway Papillomas Oct 31, 20266 min read Read the story Drugs & Biologics FDA Approves Ilumya for Psoriatic Arthritis Oct 31, 20265 min read Read the story Spotlight Aspen Neuroscience Prices $140.6M Nasdaq IPO Oct 30, 20267 min read Read the story Spotlight Deep Reasoning AI Secures FDA Clearance for NeuroDR Oct 30, 20267 min read Read the story Spotlight Roche Wins CE Mark for cobas smart e Immunoanalyser Oct 30, 20267 min read Read the story For Physicians UK Clears Oral Psoriasis Pill Already Used in US Oct 30, 20269 min read Read the story Devices & Diagnostics FDA Revises Its Drug-Delivery Device Test Guidance Oct 30, 20266 min read Read the story Manufacturing & Quality HHS Clears Compounding of Six Unapproved Peptides Oct 30, 20267 min read Read the story Guidance & Policy FDA Drafts a Mandatory eSTAR Path for Device Trials Oct 30, 20266 min read Read the story For Physicians CHMP Backs Second Achondroplasia Drug, Dosed Weekly Oct 29, 20267 min read Read the story Spotlight Xbrane Wins FDA Nod for Lucamzi Eye Biosimilar Oct 29, 20267 min read Read the story Spotlight Medicovestor Earns FDA Fast Track for Pancreatic ADC Oct 29, 20266 min read Read the story Drugs & Biologics FDA Expands Talzenna-Xtandi to Earlier Prostate Cancer Oct 29, 20266 min read Read the story Manufacturing & Quality FDA Warns Baxter Over Repeat Sterile-Plant Failures Oct 29, 20265 min read Read the story For Physicians FDA Extends Once-Weekly Awiqli to Pediatric T2D Oct 28, 202611 min read Read the story For Physicians FDA Approves First Generic Combined Menopause Patch Oct 28, 20269 min read Read the story Spotlight Cosette Earns Its First FDA Drug Approval With EVOXAC Oct 28, 20267 min read Read the story Guidance & Policy FDA Drafts a Path to One BLA Per Gene-Editing Family Oct 28, 20266 min read Read the story Devices & Diagnostics FDA Clears Sekisui's OSOM COVID-19/Flu Combo Test Oct 28, 20265 min read Read the story Drugs & Biologics MHRA Clears First Oral IL-23 Pill for Psoriasis Oct 28, 20266 min read Read the story For Physicians FDA Approves Second Device for Tricuspid Repair Oct 27, 20268 min read Read the story Spotlight Lucid Begins Medicare Payment for EsoGuard DNA Test Oct 27, 20267 min read Read the story Spotlight Sumitomo Earns FDA Breakthrough Tag for Enzomenib Oct 27, 20267 min read Read the story Spotlight Elucid Wins FDA Clearance for Its FFR-IQ Software Oct 27, 20267 min read Read the story Drugs & Biologics FDA Approves Weekly Insulin Awiqli for Pediatric T2D Oct 27, 20265 min read Read the story Devices & Diagnostics FDA Clears bioMérieux’s Point-of-Care Vaginitis Panel Oct 27, 20265 min read Read the story Guidance & Policy FDA Finalizes Its Mandatory Cosmetics Recall Guidance Oct 27, 20265 min read Read the story For Physicians FDA Extends Orladeyo Pellets to Teens, Adults With HAE Oct 26, 20266 min read Read the story For Physicians FDA Approves Hibsago, First Antisense Hepatitis B Drug Oct 26, 20269 min read Read the story Spotlight City Therapeutics Closes $230M Nasdaq IPO Oct 26, 20266 min read Read the story Spotlight RIVANNA Wins FDA Clearance for BoneEnhance AI Oct 26, 20266 min read Read the story Spotlight Teleflex's Freesolve Scaffold Wins 2nd Breakthrough Tag Oct 26, 20267 min read Read the story Manufacturing & Quality FDA Widens Olympus Import Alert to GI Scopes Oct 26, 20266 min read Read the story Drugs & Biologics FDA Extends Orladeyo Pellets to Patients 12 and Up Oct 26, 20265 min read Read the story Manufacturing & Quality Safety Group Asks FDA to Block Peptide Compounding Oct 26, 20267 min read Read the story For Physicians FDA Clears Lightning CAVT for Deep Vein Thrombosis Oct 25, 202611 min read Read the story For Physicians Ultomiris Cleared for IgAN; Kidney Benefit Still Unproven Oct 25, 202612 min read Read the story Spotlight Nuravax Wins FDA Fast Track for Alzheimer's Vaccine Oct 25, 20267 min read Read the story Spotlight Penumbra's Lightning CAVT Clears FDA for DVT Oct 25, 20267 min read Read the story Drugs & Biologics FDA Clears First C5 Inhibitor for IgA Kidney Disease Oct 25, 20266 min read Read the story Guidance & Policy FDA Launches Neuroscience Hub, Starts on Alzheimer's Oct 25, 20265 min read Read the story Drugs & Biologics CHMP Rejects Omeros' Narsoplimab for Second Time Oct 25, 20266 min read Read the story For Physicians FDA Approves Subcutaneous-Only Skyrizi Induction Oct 24, 20268 min read Read the story Spotlight Coreline Soft Wins 13th FDA Clearance for Aortic AI Oct 24, 20266 min read Read the story Spotlight Eko Health Launches CORE 300 Hybrid AI Stethoscope Oct 24, 20266 min read Read the story Spotlight Samsung Bioepis Earns FDA Fast Track for First ADC Oct 24, 20267 min read Read the story Drugs & Biologics FDA Approves At-Home SKYRIZI Start for Crohn's Oct 24, 20267 min read Read the story Devices & Diagnostics FDA Clears Edwards' Pascal for Tricuspid Repair Oct 24, 20267 min read Read the story Guidance & Policy EMA, African Regulators Set Rules for Ebola Trials Oct 24, 20268 min read Read the story For Physicians FDA Narrows Pembrolizumab's TMB-High Cancer Approval Oct 23, 20269 min read Read the story Spotlight Altay Raises $37M for First Oral FSHD Drug Oct 23, 20267 min read Read the story Spotlight NeuroXT Clears FDA for Alzheimer's Risk AI Tool Oct 23, 20266 min read Read the story Spotlight Arrowhead Wins UK Nod for Rare-Disease Drug Redemplo Oct 23, 20267 min read Read the story Drugs & Biologics FDA Approves GSK's Hibsago for Chronic Hepatitis B 6 min read Read the story Guidance & Policy FDA Finalizes Guidance on Drug Companion Apps 6 min read Read the story Devices & Diagnostics FDA Flags Recalled Infusion Sets in Cardinal Kits 6 min read Read the story Spotlight Nouscom Raises $135M for Cancer-Prevention Vaccine Oct 22, 20267 min read Read the story Spotlight Solventum Clears FDA to Pair Two Wound Therapies Oct 22, 20267 min read Read the story Spotlight SAB Bio Wins FDA Fast Track for Diabetes Drug Oct 22, 20267 min read Read the story Devices & Diagnostics UK Confirms Indefinite Recognition of CE-Marked Devices Oct 22, 20266 min read Read the story For Physicians FDA Clears AI Tool to Score Breast Cancer Recurrence Oct 21, 20269 min read Read the story For Physicians FDA Approves First Immunotherapy for Rectal Cancer Oct 21, 202610 min read Read the story Spotlight Cytokinetics Expands MYQORZO Access to Canada Oct 21, 20267 min read Read the story Spotlight Gore Wins FDA Nod for First On-Label Bridging Stent Oct 21, 20267 min read Read the story Spotlight Estuary Launches With $103M for Kidney Gene Therapy Oct 21, 20267 min read Read the story Drugs & Biologics FDA Approves GSK's Jemperli for Rectal Cancer Oct 21, 20266 min read Read the story Devices & Diagnostics FDA Approves Haemonetics' PerQseal Elite Device Oct 21, 20266 min read Read the story Drugs & Biologics MHRA Authorises Redemplo for Rare Lipid Disorder Oct 21, 20265 min read Read the story Spotlight Sensydia Lands $6M to Push Heart Monitor to FDA Oct 20, 20266 min read Read the story Spotlight Verastem Raises $250M, Aligns FDA on Phase 3 Oct 20, 20267 min read Read the story Drugs & Biologics CHMP Recommends Lilly's Oral GLP-1 Foundayo Oct 20, 20266 min read Read the story Devices & Diagnostics FDA Clears Twiist Pump for Type 2 Diabetes Oct 20, 20266 min read Read the story Drugs & Biologics FDA Approves Autoinjector for UCB's Zilbrysq Oct 20, 20266 min read Read the story For Physicians FDA Approves Enspryng, First At-Home Thyroid Eye Drug Oct 19, 202611 min read Read the story Spotlight Microbiotica Raises £36M to Push MB310 to Phase 2 Oct 19, 20266 min read Read the story Drugs & Biologics FDA Flags Counterfeit Eye Drops in Several States Oct 19, 20265 min read Read the story Guidance & Policy FDA Launches Rare Disease Drug Review Framework Oct 19, 20266 min read Read the story Drugs & Biologics FDA Expands Anktiva to Papillary-Only Bladder Cancer Oct 19, 20266 min read Read the story Spotlight OMass Therapeutics Raises $310M Series C Oct 18, 20267 min read Read the story Spotlight Opus Genetics Wins Second FDA Nod for RYZUMVI Oct 18, 20266 min read Read the story Spotlight SimBioSys Earns FDA Clearance for TumorSight Risk Oct 18, 20266 min read Read the story Drugs & Biologics MHRA Orders Boxed Suicide-Risk Warning on Antidepressants Oct 18, 20266 min read Read the story Drugs & Biologics FDA Clears First OTC Apraclonidine Drop, Alcon's Brytly Oct 18, 20265 min read Read the story Guidance & Policy FDA Sets Jan. 2027 Cutoff to Reject Bad eCTD Submissions Oct 18, 20265 min read Read the story For Physicians EMA Recommends First RAS Inhibitor for Pancreatic Cancer Oct 17, 20269 min read Read the story Spotlight Centinel Spine Completes 2-Level Cervical Disc Set Oct 17, 20265 min read Read the story Spotlight Ascendis Wins CHMP Backing for Achondroplasia Drug Yuviwel Oct 17, 20266 min read Read the story Spotlight Marengo Earns Second FDA Fast Track for Tumor Drug Oct 17, 20265 min read Read the story Drugs & Biologics FDA Approves Enspryng as First At-Home TED Treatment Oct 17, 20266 min read Read the story Manufacturing & Quality Par Health Recalls Argatroban Over Particulate Matter Oct 17, 20265 min read Read the story Drugs & Biologics EMA Recommends EU Approval for RAS-Inhibitor Rasonque Oct 17, 20266 min read Read the story For Physicians FDA Flags Edwards SAPIEN M3 Delivery System After Death Oct 16, 20268 min read Read the story Spotlight Iambic Prices $150M IPO to Fund AI-Built Cancer Drug Oct 16, 20267 min read Read the story Spotlight E2 Clears FDA Hurdle for Blood-Saving Clot Device Oct 16, 20267 min read Read the story Spotlight Soufflé Raises $135M to Push RNA Drug Into the Clinic Oct 16, 20267 min read Read the story Guidance & Policy MHRA Publishes Strategy 2030 for the AI Era Oct 16, 20266 min read Read the story Drugs & Biologics FDA Accepts First Keytruda Biosimilar for Review Oct 16, 20266 min read Read the story Manufacturing & Quality Olympus Discloses New FDA Warning Letter Over QMS Oct 16, 20266 min read Read the story For Physicians FDA Clears Neurora AI Tool for Autism Diagnosis Oct 14, 20268 min read Read the story Spotlight Vantis Vascular Wins FDA Clearance for 6F CrossFAST Oct 14, 20268 min read Read the story Spotlight Leads Biolabs Wins Second FDA Fast Track for BTC Drug Oct 14, 20269 min read Read the story Spotlight RougeTx Raises $58 Million Series A for HHT Drug RTX-001 Oct 14, 20268 min read Read the story Devices & Diagnostics WHO Expands Device Prequalification to Condoms, IUDs Oct 14, 20266 min read Read the story Drugs & Biologics MHRA Authorises Lilly's Weekly Insulin Onswik Oct 14, 20265 min read Read the story Guidance & Policy FDA Raises Device User Fees About 10% for FY2027 Oct 14, 20265 min read Read the story For Physicians FDA Clears Patient App for Abbott's CardioMEMS Monitor Oct 13, 20269 min read Read the story Spotlight Novartis Earns FDA Nod for First Dermographism Drug Oct 13, 20266 min read Read the story Spotlight Retension Pharmaceuticals Prices $45M Nasdaq IPO Oct 13, 20266 min read Read the story Spotlight icotec Wins Medicare Add-On Payment for CMORE CT Oct 13, 20266 min read Read the story Drugs & Biologics AbbVie's Temab-A Wins Two FDA Breakthrough Tags Oct 13, 20265 min read Read the story Devices & Diagnostics FDA Expands Okami's LOBO Occluder to Veins Oct 13, 20264 min read Read the story For Physicians FDA Adds Tucatinib to HER2+ Breast Cancer Maintenance Oct 12, 20269 min read Read the story Spotlight HeartBeam Wins FDA Breakthrough Status for Heart Attacks Oct 12, 20267 min read Read the story Spotlight Matchpoint Raises $150M to Push a Covalent Drug to Clinic Oct 12, 20267 min read Read the story Spotlight Zydus Launches First Generic Adempas Rival in the US Oct 12, 20266 min read Read the story Drugs & Biologics FDA Approves Teva's Weltruza for Schizophrenia Oct 12, 20266 min read Read the story Devices & Diagnostics FDA Grants Breakthrough Status to Natera Cancer Test Oct 12, 20265 min read Read the story Devices & Diagnostics FDA Clears Urolution OpenFlo Urinary Catheter Oct 12, 20265 min read Read the story For Physicians FDA Approves First Spiral-Optic Presbyopia Lens Oct 11, 20269 min read Read the story Spotlight Sava Lands $36M Series B Led by Ascensia Oct 11, 20266 min read Read the story Spotlight TRexBio Raises $117M in Nasdaq IPO for Treg Drug Oct 11, 20266 min read Read the story Spotlight Wellysis Wins FDA Clearance for S-Patch CardioAI Oct 11, 20266 min read Read the story Drugs & Biologics Ultragenyx Sells Priority Review Voucher for $210M Oct 11, 20265 min read Read the story Devices & Diagnostics FDA Links Philips Lumify Ultrasound Bug to Four Deaths Oct 11, 20265 min read Read the story Drugs & Biologics FDA Approves Hovilpri for Drug-Resistant Herpes Lesions Oct 11, 20265 min read Read the story For Physicians NY Declares Measles Emergency, Widens Who Can Vaccinate Oct 10, 20268 min read Read the story For Physicians Brevital Recall Hits an OR and ECT Anesthesia Drug Oct 10, 20267 min read Read the story Spotlight Vir Biotechnology Wins FDA Fast Track for VIR-5500 Oct 10, 20266 min read Read the story Spotlight Argus Cognitive Earns FDA Clearance for Neurora Oct 10, 20265 min read Read the story Spotlight Medical Microinstruments Lands $125M for Symani Oct 10, 20266 min read Read the story Clinical Trials EMA Makes Pre-CTA Trial Advice Pilot Permanent Oct 10, 20265 min read Read the story Guidance & Policy FDA Finalizes Biosimilar Manufacturing-Change Rules Oct 10, 20266 min read Read the story Manufacturing & Quality Par Health Recalls Brevital Sodium Over Cellulose Oct 10, 20265 min read Read the story For Physicians FDA Approves First Adjuvant Immunotherapy for Colon Cancer Oct 9, 20269 min read Read the story Spotlight Perspective Wins FDA Fast Track for PSV359 in Rare Sarcoma Oct 9, 20266 min read Read the story Spotlight Lipocine, Verity Win Health Canada Nod for TLANDO Oct 9, 20266 min read Read the story Spotlight Zenflow Lands $52M Series D, Cook Medical Distribution Oct 9, 20266 min read Read the story Drugs & Biologics FDA Approves Tucatinib Maintenance for HER2+ Cancer Oct 9, 20266 min read Read the story Guidance & Policy FDA Eases 510(k) Rule for Federal Drug-Test Devices Oct 9, 20266 min read Read the story Guidance & Policy FDA Finalizes Class II Rule for Hyperoxia Monitors Oct 9, 20266 min read Read the story For Physicians TTFields Device Now Part of Pancreatic Cancer Care Oct 8, 20269 min read Read the story For Physicians MHRA Approves First Drug for Malignant Ascites Oct 8, 20269 min read Read the story Spotlight MRI2CT Clears FDA Hurdle for AI Spine Imaging Oct 8, 20266 min read Read the story Spotlight Novocure Wins Japan Approval for Pancreatic Cancer Device Oct 8, 20266 min read Read the story Manufacturing & Quality FDA Warns Amazon, Walmart Over Herpes Cream Claims Oct 8, 20267 min read Read the story Manufacturing & Quality FDA Recall: Compounded Glutathione Tied to ED Visits Oct 8, 20266 min read Read the story Drugs & Biologics MHRA Approves Korjuny, a Revived Ascites Antibody Oct 8, 20266 min read Read the story For Physicians FDA Clears AI to Quantify Liver, Visceral Fat on MRI Oct 7, 202610 min read Read the story Spotlight SeaStar Earns 7th FDA Breakthrough Device Nod Oct 7, 20266 min read Read the story Spotlight TELA Bio Wins FDA Clearance for Liora Mesh Oct 7, 20265 min read Read the story Spotlight KymaThera Raises $80M to Advance Cancer Drug K-1728 Oct 7, 20265 min read Read the story Guidance & Policy UK Backs All 44 Recommendations for NHS AI Oct 7, 20266 min read Read the story Guidance & Policy FDA Opens a 510(k) Path for Cancer Gene Panels Oct 7, 20265 min read Read the story Clinical Trials FDA Opens Docket on Ibogaine Trial Design, Safety Oct 7, 20265 min read Read the story For Physicians FDA-Cleared Sepsis Panel Now Flags Resistance Genes Oct 6, 20268 min read Read the story Spotlight Curaleaf Launches First TGA-Registered Cannabis Inhaler Oct 6, 20267 min read Read the story Spotlight Trethera Lands Second Fast Track for Lung Cancer Drug Oct 6, 20266 min read Read the story Spotlight AIRS Medical Clears FDA 510(k) for Body-Fat MRI AI Oct 6, 20267 min read Read the story Devices & Diagnostics FDA Classifies Dräger Neonatal Circuit Recall as Class I Oct 6, 20266 min read Read the story Guidance & Policy Court Sets Oct. 7 Deadline for FDA Mifepristone Review Oct 6, 20267 min read Read the story Manufacturing & Quality FDA Hits Fresenius Kabi With Second Warning Letter Oct 6, 20267 min read Read the story For Physicians FDA's Camzyos Teen Label Requires CYP2C19 Testing Oct 5, 20269 min read Read the story For Physicians FDA Approves Jaypirca for Frontline CLL/SLL Oct 5, 202610 min read Read the story Guidance & Policy EU Council Adopts Pharma Package, Sends to Parliament Oct 5, 20266 min read Read the story Drugs & Biologics Alvotech Wins FDA Nod to Double Simlandi Production Oct 5, 20265 min read Read the story Devices & Diagnostics Medtronic Wins FDA Breakthrough Tag for Below-Knee PAD Oct 5, 20265 min read Read the story For Physicians FDA Approves Juvmo, First D1/D5 Agonist for Parkinson's Oct 4, 202610 min read Read the story For Physicians Daiichi Sankyo, Merck Pull Lung Cancer ADC Filing Oct 4, 20269 min read Read the story Spotlight UltraSight Raises $24M to Scale AI Cardiac Ultrasound Oct 4, 20266 min read Read the story Spotlight Pyxis Oncology Prices $110M Raise for MICVO's Phase 3 Oct 4, 20267 min read Read the story Drugs & Biologics Pierre Fabre Refiles Ebvallo BLA After FDA Reversal Oct 4, 20265 min read Read the story Guidance & Policy FDA's CDRH Flags AI and Surgical Robots for FY2027 Oct 4, 20264 min read Read the story Guidance & Policy Canada's New Controlled Substances Rules Take Effect Oct 4, 20264 min read Read the story For Physicians FDA Approves First Expandable Pulmonary Valve for Kids Oct 2, 202610 min read Read the story Spotlight VB Spine Wins FDA Breakthrough Nod for Scoliosis Blood Test Oct 2, 20267 min read Read the story Spotlight Celcuity Starts Shipping First Wild-Type Breast Cancer Drug Oct 2, 20267 min read Read the story Drugs & Biologics FDA Approves Camzyos for Teens With Obstructive HCM Oct 2, 20266 min read Read the story Drugs & Biologics FDA Advisers Back 2027 Flu Vaccine Strains, 9-0 Oct 2, 20265 min read Read the story Guidance & Policy EMA, MHRA Lead Call for Animal-Testing Alternatives Oct 2, 20265 min read Read the story Spotlight AnaCardio Raises €62.5M to Fund Heart Drug Phase 2b Oct 1, 20266 min read Read the story Spotlight EBR Systems Wins Medicare Pay Rise for Its WiSE Heart Device Oct 1, 20266 min read Read the story Spotlight QIAGEN Completes US Sepsis Panel Duo With FDA Clearance Oct 1, 20266 min read Read the story Devices & Diagnostics FDA Clears Medtronic's Affera Prism-2 Mapping Software Oct 1, 20267 min read Read the story Devices & Diagnostics FDA Clears Ceribell's New EEG Monitoring Tools Oct 1, 20266 min read Read the story Devices & Diagnostics FDA Clears VCD Medical's First US Vein-Closure Device Oct 1, 20266 min read Read the story For Physicians FDA Clears Tempus AI Tool to Flag Mitral Regurgitation Sep 30, 20268 min read Read the story For Physicians FDA Approves Lyrfigtu, Third FGFR2 Drug for Bile Duct Cancer Sep 30, 202611 min read Read the story Spotlight Aidoc Wins Third FDA Breakthrough Nod for X-Ray AI Sep 30, 20267 min read Read the story Spotlight Glycomine Lands Breakthrough Status for Rare CDG Drug Sep 30, 20266 min read Read the story Spotlight IMPACT Therapeutics Clears CHMP for Ovarian Cancer Drug Sep 30, 20267 min read Read the story Drugs & Biologics FDA Approves Teva's Denosumab Biosimilar to Xgeva Sep 30, 20266 min read Read the story Guidance & Policy EU's IVDR Class C Notified-Body Deadline Passes Sep 30, 20267 min read Read the story Guidance & Policy CMS Ends Breakthrough Devices' Medicare Fast Track Sep 30, 20267 min read Read the story For Physicians CMS Ends TAVR's Mandatory Two-Operator Rule Sep 29, 20269 min read Read the story For Physicians FDA Clears SI-BONE Implant for Fusion Screw Loosening Sep 29, 20268 min read Read the story Spotlight Quoin Wins First-Ever Fast Track for Peeling Skin Syndrome Sep 29, 20267 min read Read the story Spotlight Kasvu Raises €30M Series A for TrkB Depression Drug Sep 29, 20267 min read Read the story Spotlight CapsoVision Clears FDA for AI-Assisted Capsule Endoscopy Sep 29, 20267 min read Read the story Drugs & Biologics FDA Approves First-Ever Treatment for MCT8 Deficiency Sep 29, 20267 min read Read the story Guidance & Policy TGA Sues BioV8 Directors Over Illegal Peptide Ads Sep 29, 20267 min read Read the story Devices & Diagnostics Route 92 Medical Clears FDA for FreeClimb 46 Sep 29, 20265 min read Read the story For Physicians FAYUVI's Label Limits It to Early-Stage Sanfilippo Sep 28, 20268 min read Read the story For Physicians FDA Approves First Drug for Relapsing Nephrotic Syndrome Sep 28, 20267 min read Read the story Spotlight ADARx Prices $446M IPO to Fund Onvuzosiran Sep 28, 20267 min read Read the story Spotlight Xenix Medical Clears FDA for Riva Anchor SI Implant Sep 28, 20266 min read Read the story Spotlight LEO Pharma Wins CHMP Nod to Treat Teen Eczema Sep 28, 20267 min read Read the story Manufacturing & Quality FDA Cites Sterility Risk in Spectra Saline Flush Recall Sep 28, 20266 min read Read the story Drugs & Biologics FDA Approves Gazyva for Childhood Nephrotic Syndrome Sep 28, 20266 min read Read the story Guidance & Policy FDA and MDIC Meet to Set Device Science Priorities Sep 28, 20265 min read Read the story For Physicians FDA Approves Oral SERD Combo for ESR1+ Breast Cancer Sep 28, 20268 min read Read the story For Physicians FDA Approves Belzutifan-Lenvatinib Combo for Kidney Cancer Sep 28, 20267 min read Read the story For Physicians FDA Approves Onswik, Lilly's Once-Weekly Basal Insulin Sep 27, 202614 min read Read the story For Physicians FDA Label Now Backs Early Winrevair Use in PAH Sep 27, 20267 min read Read the story For Physicians FDA Recalls Vitruvias Thyroid Tablets Over Superpotency Sep 27, 20266 min read Read the story Spotlight Marani Health Clears FDA for M•care Fetal Monitor Sep 27, 20267 min read Read the story Spotlight Incyte Lands EU Backing for First Oral HS Pill Sep 27, 20267 min read Read the story Spotlight Rhythm Expands IMCIVREE to Acquired Obesity in Canada Sep 27, 20267 min read Read the story Guidance & Policy FDA Nominee Overton Grilled on Mifepristone, Vaccines Sep 27, 20265 min read Read the story Manufacturing & Quality Sanofi Recalls Insulin Pens, Sarclisa Over Cold Chain Sep 27, 20264 min read Read the story Devices & Diagnostics France Pulls Getinge Vascular Grafts Over Yarn Defect Sep 27, 20264 min read Read the story Spotlight Mirum Wins FDA Nod for Third FOP Drug Atebrioz Sep 26, 20266 min read Read the story Spotlight Biolinq's Shine Clears FDA for OTC Sale Sep 26, 20266 min read Read the story Spotlight Precision Neuroscience Raises $250M for BCI Sep 26, 20267 min read Read the story Drugs & Biologics EU Approves First Drug for Cerebral ALD Sep 26, 20265 min read Read the story Guidance & Policy FDA Drafts First Guidance for Surgical Robots Sep 26, 20266 min read Read the story Drugs & Biologics FDA Clears Welireg-Lenvima Combo for Kidney Cancer Sep 26, 20266 min read Read the story Spotlight Betta's Gevalka Clears CHMP for Lung Cancer Sep 25, 20266 min read Read the story Spotlight BigHat Biosciences Lands $75M for AI Antibodies Sep 25, 20266 min read Read the story Devices & Diagnostics FDA Panel Narrowly Backs GRAIL's Galleri Test Sep 25, 20266 min read Read the story Drugs & Biologics MHRA Approves Lurbinectedin Combo for Lung Cancer Sep 25, 20265 min read Read the story Devices & Diagnostics Director Sentenced Over Fake CE-Marked Baby Devices Sep 25, 20266 min read Read the story Spotlight CHMP Recommends Zealand's Zeydovio for Bowel Disease Sep 24, 20266 min read Read the story Spotlight HighLife Raises $90M for US Valve Trial, EU Growth Sep 24, 20265 min read Read the story Spotlight TriSalus Wins FDA Clearance for TriNav Advance Sep 24, 20265 min read Read the story Manufacturing & Quality FDA Hits Empower Pharmacy With Fifth Warning Letter Sep 24, 20266 min read Read the story Devices & Diagnostics FDA Approves Cordis' Sirolimus-Eluting Balloon Sep 24, 20265 min read Read the story Guidance & Policy MHRA Funds Four New Regulatory Science Centres Sep 24, 20265 min read Read the story Spotlight Traferox Lands FDA Clearance for X°Port Heart System Sep 23, 20266 min read Read the story Spotlight Powerful Medical Wins First FDA Nod for AI-ECG Tool Sep 23, 20266 min read Read the story Drugs & Biologics FDA Expands WINREVAIR Label With HYPERION Data Sep 23, 20266 min read Read the story Devices & Diagnostics FDA Grants Second Breakthrough Nod to UTI Test Panel Sep 23, 20265 min read Read the story Guidance & Policy TGA Bars New Andrographis Listings Over Anaphylaxis Sep 23, 20266 min read Read the story Spotlight Electra Therapeutics Prices $350M IPO for sHLH Drug Sep 22, 20266 min read Read the story Spotlight Curium Wins FDA Approval for First Radioligand Rival Sep 22, 20266 min read Read the story Spotlight Dialybrid Raises €15M, Implants First Vascular Graft Sep 22, 20266 min read Read the story Drugs & Biologics CHMP Clears First mAb Biosimilar Under New EU Path Sep 22, 20266 min read Read the story Guidance & Policy FDA Swaps 'Animal Testing' for 'Nonclinical' in Rules Sep 22, 20265 min read Read the story Devices & Diagnostics MHRA Curbs Wireless Fetal Monitor Signal Mix-Ups Sep 22, 20265 min read Read the story Spotlight Koning Health Wins TGA Approval for Breast CT System Sep 21, 20266 min read Read the story Spotlight SK Biopharmaceuticals Completes Japan Epilepsy Approval Sep 21, 20266 min read Read the story Spotlight Circle Pharma Raises $92.5M Series E for Cancer Drug Sep 21, 20266 min read Read the story Drugs & Biologics FDA Grants Fast Track to PureTech's MDS Antibody Sep 21, 20265 min read Read the story Drugs & Biologics CHMP Backs Corcept's Lifyorli for Ovarian Cancer Sep 21, 20266 min read Read the story Spotlight Sling Nets $123M to Push Eye Drug Into Phase 3 Sep 20, 20266 min read Read the story Spotlight Cyllene Wins FDA RMAT Status for Bladder Gene Therapy Sep 20, 20266 min read Read the story Drugs & Biologics CHMP Backs AstraZeneca's Klygefa for Rare Disorder Sep 20, 20265 min read Read the story Drugs & Biologics FDA Approves Lilly's Inluriyo-Verzenio Combo Sep 20, 20266 min read Read the story Guidance & Policy FDA Drafts an eSTAR Template for Device PMAs Sep 20, 20265 min read Read the story Spotlight RegCell Raises $66M for Nobel-Backed Treg Therapy Sep 19, 20266 min read Read the story Spotlight Shoulder Innovations Clears FDA Hurdle for N-22 Implant Sep 19, 20265 min read Read the story Spotlight FemPulse Earns CE Mark for Wearable Bladder Ring Sep 19, 20266 min read Read the story Drugs & Biologics FDA Approves First Drug for Ataxia in Rare A-T Sep 19, 20265 min read Read the story Devices & Diagnostics FDA Clears Neptune Medical's Robotic Endoscope Sep 19, 20265 min read Read the story Drugs & Biologics CHMP Recommends Novo's Frehemgo for Haemophilia A Sep 19, 20265 min read Read the story Spotlight Matisse Raises €14M for Phase 2 Sepsis Drug Trial Sep 18, 20265 min read Read the story Spotlight CorTec Lands Second FDA Breakthrough Nod for BCI Sep 18, 20266 min read Read the story Spotlight Scholar Rock Wins FDA Nod for First SMA Muscle Drug Sep 18, 20266 min read Read the story Drugs & Biologics FDA Approves First Gene Therapy for Sanfilippo Type A Sep 18, 20265 min read Read the story Guidance & Policy FDA Denies Bid to Exempt Radiology AI From 510(k) Sep 18, 20265 min read Read the story Drugs & Biologics FDA Updates IBTROZI Label With 4-Year Response Data Sep 18, 20264 min read Read the story Drugs & Biologics FDA Clears First Skin-Cancer Photodynamic Therapy Sep 17, 20264 min read Read the story Devices & Diagnostics FDA Clears First Robotic LigaSure Vessel Sealer Sep 17, 20264 min read Read the story Devices & Diagnostics MHRA Alert: Hoist Falls Have Killed Two a Year Sep 17, 20264 min read Read the story Spotlight Pharming Wins FDA Nod to Extend Joenja to Kids Sep 17, 20265 min read Read the story Spotlight UpFront Diagnostics Earns CE Mark for Stroke Test Sep 17, 20265 min read Read the story Spotlight Emboline Clears FDA Hurdle for TAVR Debris Filter Sep 17, 20266 min read Read the story Drugs & Biologics TGA: Counterfeit Retatrutide Hid 8x-Dose Semaglutide Sep 16, 20265 min read Read the story Devices & Diagnostics FDA Breakthrough Status for Remote Robotic Stroke Device Sep 16, 20266 min read Read the story Drugs & Biologics Cogent's Bezuclastinib Notches Third Simultaneous NDA Sep 16, 20265 min read Read the story Spotlight Beta Bionics Wins FDA Clearance for Mint Patch Pump Sep 15, 20265 min read Read the story Spotlight Armata Wins Breakthrough Status for Phage Therapy AP-SA02 Sep 15, 20265 min read Read the story Spotlight Juniper Lands Breakthrough Status for Hypoxia PET Tracer Sep 15, 20265 min read Read the story Guidance & Policy FDA Hears Fight Over Who Can Give Psychedelic Therapy Sep 15, 20265 min read Read the story Drugs & Biologics RASONQUE Wins Breakthrough Status for First-Line Use Sep 15, 20264 min read Read the story Drugs & Biologics FDA Approves Telix's Pixclara for Glioma Imaging Sep 14, 20264 min read Read the story Devices & Diagnostics FDA Grants Nutromics' Patch Breakthrough Status Sep 11, 20264 min read Read the story Devices & Diagnostics FDA Clarifies Path for Spectral's Sepsis Device Sep 11, 20264 min read Read the story Guidance & Policy FDA's CDRH Launches Rare Disease Device Initiative Sep 13, 20265 min read Read the story Drugs & Biologics France Warns 1.6 Million Women on Pill Meningioma Risk Sep 13, 20265 min read Read the story Manufacturing & Quality Teva Canada Recalls Acetaminophen Over Resin Risk Sep 13, 20264 min read Read the story Guidance & Policy FDA Names Permanent CDER, CBER Chiefs, New AI Post Sep 12, 20265 min read Read the story Guidance & Policy EMA Extends PV Inspections to Cover Subcontractors Sep 12, 20264 min read Read the story Guidance & Policy MHRA Panel Proposes 'L-Plates' for AI in Healthcare Sep 12, 20264 min read Read the story Drugs & Biologics FDA Clears Hyrnuo for First-Line HER2-Mutant Lung Cancer Sep 11, 20265 min read Read the story Guidance & Policy FDA Eases Compounding Rules for Newborn IV Nutrition Sep 11, 20265 min read Read the story Drugs & Biologics EMA Reviews Injectable Iron Drugs Over Bone-Risk Reports Sep 11, 20264 min read Read the story Drugs & Biologics FDA Approves Fall 2026 COVID Shots, Keeps Narrow Use Aug 30, 20265 min read Read the story Devices & Diagnostics MHRA Flags Wear Risk in Five Modular-Neck Hip Implants Aug 30, 20265 min read Read the story Drugs & Biologics FDA Warns Alar Over Ads for Its Unapproved Ketamine Drug Aug 30, 20264 min read Read the story Guidance & Policy FDA Authorizes New JUUL2 E-Cigarette System Aug 28, 20265 min read Read the story Drugs & Biologics FDA Approves First Drug for Polycythemia Vera Aug 28, 20264 min read Read the story Drugs & Biologics FDA Approves First Oral Drug for Dermatomyositis Aug 27, 20265 min read Read the story Devices & Diagnostics FDA Clears Spineart's Robotic Spine Screw App Aug 26, 20264 min read Read the story Manufacturing & Quality Boston Scientific Cyberattack Halts Device Shipments Aug 26, 20265 min read Read the story Drugs & Biologics FDA Approves Rasonque, First RAS-Targeted Cancer Drug Aug 26, 20265 min read Read the story Devices & Diagnostics FDA Clears Abbott's Libre Duo Glucose-Ketone Monitor Aug 25, 20265 min read Read the story Drugs & Biologics FDA Approves Ziihera Regimens for Gastric Cancer Aug 25, 20265 min read Read the story Devices & Diagnostics FDA Clears Masimo's Root With LiDCO for Oxygen Delivery Aug 25, 20264 min read Read the story Drugs & Biologics EU Approves GSK's Twice-Yearly Asthma Drug Exdensur Aug 25, 20265 min read Read the story Devices & Diagnostics FDA Clears Tempus's AI Tool for Pulmonary Hypertension Aug 25, 20264 min read Read the story Guidance & Policy FDA Issues 55 New Bioequivalence Guidances for Generics Aug 25, 20265 min read Read the story Drugs & Biologics FDA Extends Review of Capricor's Duchenne Therapy Aug 24, 20265 min read Read the story Devices & Diagnostics FDA Classifies Enroute Carotid Recall as Class I Aug 24, 20265 min read Read the story Guidance & Policy FDA Recognizes 14 Updated Medical Device Standards Aug 24, 20265 min read Read the story Drugs & Biologics EU Clears Tecvayli Plus Daratumumab for Myeloma Aug 24, 20265 min read Read the story Guidance & Policy FDA Finalizes Guidance on Generic Drug TE Codes Aug 23, 20266 min read Read the story Guidance & Policy FDA Finalizes FAQ Guide for Cell, Gene Therapies Aug 23, 20266 min read Read the story Devices & Diagnostics MHRA Warns Against Infant Gas-Relief Catheters Aug 23, 20265 min read Read the story Guidance & Policy FDA Revises Guidance on ANDA vs. 505(b)(2) Filings Aug 20, 20265 min read Read the story Drugs & Biologics FDA Approves First Gene Therapy for GSDIa Aug 20, 20266 min read Read the story Devices & Diagnostics FDA Authorizes First Robotic Blood-Draw Device Aug 20, 20266 min read Read the story Guidance & Policy FDA Eases Path for Cancer Companion Diagnostics Aug 19, 20265 min read Read the story Guidance & Policy MHRA Clarifies UK Path for Microbiome Medicines Aug 19, 20265 min read Read the story Guidance & Policy FDA Weighs a Competency Test for AI Medical Devices Aug 19, 20265 min read Read the story Drugs & Biologics FDA Clears LEROCHOL Autoinjector, Adds CV Risk Claim Aug 18, 20265 min read Read the story Guidance & Policy FDA's GDUFA IV Plan Would Raise Foreign Drug Fees Aug 18, 20265 min read Read the story Devices & Diagnostics FDA Sets a September Panel on GRAIL's Galleri Blood Test Aug 17, 20266 min read Read the story Manufacturing & Quality FDA Flags Novo Nordisk's Indiana Plant as Highest Risk Aug 17, 20266 min read Read the story Guidance & Policy MHRA to Require Briefing Documents for Scientific Advice Aug 17, 20265 min read Read the story Guidance & Policy FDA Sets September Meeting on PDUFA VIII Fee Deal Aug 16, 20265 min read Read the story Devices & Diagnostics FDA Grants Breakthrough Status to Freenome Lung Test Aug 16, 20265 min read Read the story Drugs & Biologics FDA Grants Hearing on Generic Concerta After Decade Aug 16, 20265 min read Read the story Guidance & Policy FDA Drafts New Guidance on Drug Container Closures Aug 15, 20265 min read Read the story Drugs & Biologics MHRA Approves Vimseltinib for Giant Cell Tumours Aug 15, 20264 min read Read the story Guidance & Policy FDA Widens Type D Meetings, Narrows INTERACT Use Aug 14, 20265 min read Read the story Drugs & Biologics FDA Approves Bristol Myers' First CELMoD for Myeloma Aug 14, 20264 min read Read the story Devices & Diagnostics TGA Suspends Supply of Corpuls Defibrillators Aug 14, 20265 min read Read the story Drugs & Biologics UK First in Europe to Approve Lilly's Foundayo Pill Aug 13, 20265 min read Read the story Manufacturing & Quality FDA Posts First Two Warning Letters Under New QMSR Aug 13, 20266 min read Read the story Clinical Trials FDA Warns Investigator Over Trial Drug Accountability Aug 13, 20265 min read Read the story Devices & Diagnostics FDA Lets Proscia Add Scanners Without New 510(k)s Aug 6, 20265 min read Read the story Devices & Diagnostics MHRA Lifts Suspension on Belzer Organ-Preservation Fluid Aug 6, 20264 min read Read the story Devices & Diagnostics FDA Clears Sight Sciences' OMNI Ultra for Glaucoma Aug 4, 20265 min read Read the story Devices & Diagnostics MHRA Flags Ventilator Failure Risk in Dräger Atlan Units Aug 4, 20265 min read Read the story Manufacturing & Quality FDA Launches Council to Overhaul Its Inspections Aug 3, 20266 min read Read the story Drugs & Biologics FDA Approves Replimune's Twice-Rejected Melanoma Drug Aug 6, 20266 min read Read the story Drugs & Biologics FDA Approves Takeda's Orzeyful for Narcolepsy Type 1 Aug 5, 20264 min read Read the story Clinical Trials MHRA Plans a 14-Day First Review for Phase 1 Trials Aug 4, 20265 min read Read the story Drugs & Biologics FDA Approves First mRNA Flu Vaccine, Moderna's mFLUSIVA Aug 5, 20266 min read Read the story Devices & Diagnostics FDA Clears BlueWind's Revi Extend Bladder Implant Aug 5, 20265 min read Read the story Drugs & Biologics MHRA's ILAP Passports Go to Liver Cancer, Dementia Drugs Aug 4, 20265 min read Read the story Devices & Diagnostics FDA Classifies Ventilator, Heart-Pump Recalls as Class I Aug 3, 20265 min read Read the story Guidance & Policy FDA Reopens Comment Period on Title 21 Terminology Rule Aug 3, 20264 min read Read the story Guidance & Policy FDA Drafts Rules for Biosimilar Autoinjectors, Syringes Aug 3, 20265 min read Read the story Clinical Trials FDA Debars Research Site Owners Who Faked Trial Data Aug 3, 20265 min read Read the story Drugs & Biologics FDA Grants Breakthrough Status to Lilly's KRAS Drug Aug 3, 20264 min read Read the story Drugs & Biologics FDA Panel Votes 9-3 Against Capricor's DMD Heart Drug Aug 2, 20266 min read Read the story Drugs & Biologics FDA Licenses the First Freeze-Dried Plasma for the US Aug 2, 20265 min read Read the story Guidance & Policy FDA Finalizes Adhesion Rules for Generic Skin Patches Aug 2, 20265 min read Read the story Clinical Trials FDA Finalizes Three Cancer Trial Eligibility Guidances Jul 30, 20265 min read Read the story Guidance & Policy MHRA Draws the Line on AI Scribes as Medical Devices Jul 29, 20265 min read Read the story Guidance & Policy FDA Gives Home COVID Tests a Permanent Class II Address Jul 27, 20265 min read Read the story Drugs & Biologics FDA Approves MannKind's 10-Second Heart-Failure Autoinjector Jul 27, 20265 min read Read the story Drugs & Biologics CHMP Rejects Arimoclomol Again; Zevra Seeks Re-Examination Jul 27, 20266 min read Read the story Drugs & Biologics FDA's Cell Therapy Panel Revisits a Once-Rejected DMD Drug Jul 26, 20266 min read Read the story Drugs & Biologics CHMP Backs the EU's First Refillable Eye Implant Jul 26, 20266 min read Read the story Manufacturing & Quality FDA Publishes Its Playbook for Fast-Track CMC Readiness Jul 26, 20265 min read Read the story Sponsored Inside the Free 510(k) Course Built From the Primary Record Jul 26, 20264 min read Read the story Devices & Diagnostics FDA Picks Dexcom as First TEMPO Pilot Participant Jul 24, 20266 min read Read the story Drugs & Biologics MHRA Approves the World's First Low-Carbon Asthma Inhaler Jul 24, 20265 min read Read the story Guidance & Policy Brussels Says Only Manufacturers May Assign a Device's UDI Jul 24, 20265 min read Read the story Drugs & Biologics FDA Sets a July 30 Panel on Replimune's Melanoma Drug Jul 17, 20265 min read Read the story Guidance & Policy FDA Can Now Ask the Public for OTC Monograph Data Jul 17, 20265 min read Read the story Guidance & Policy FDA Retires a 1995 Guidance on Topical Steroids Jul 17, 20265 min read Read the story Guidance & Policy MDUFA VI: The Draft Deal Is Out, With a Faster 510(k) Clock Jul 16, 20266 min read Read the story Drugs & Biologics FDA Sets a September Hearing on Psychedelic Therapy Jul 16, 20265 min read Read the story Manufacturing & Quality FDA Would Let Distributed Manufacturers Register Once Jul 16, 20266 min read Read the story Guidance & Policy FDA's OTC Monograph Meetings Guidance Is Final Jul 16, 20265 min read Read the story Clinical Trials FDA's Psychedelics Guidance Is Final, After Three Years Jul 15, 20265 min read Read the story Guidance & Policy EUDAMED's Next Deadline Is Narrower Than It Looks Jul 15, 20266 min read Read the story