Drugs & Biologics

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 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 Drugs & Biologics MHRA Clears First Oral IL-23 Pill for Psoriasis Oct 28, 20266 min read Read the story Spotlight Sumitomo Earns FDA Breakthrough Tag for Enzomenib 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 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 Drugs & Biologics FDA Extends Orladeyo Pellets to Patients 12 and Up Oct 26, 20265 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 Drugs & Biologics FDA Clears First C5 Inhibitor for IgA Kidney Disease Oct 25, 20266 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 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 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 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 Spotlight Nouscom Raises $135M for Cancer-Prevention Vaccine 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 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 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 Drugs & Biologics MHRA Authorises Redemplo for Rare Lipid Disorder Oct 21, 20265 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 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 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 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 For Physicians EMA Recommends First RAS Inhibitor for Pancreatic Cancer Oct 17, 20269 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 Drugs & Biologics EMA Recommends EU Approval for RAS-Inhibitor Rasonque Oct 17, 20266 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 Soufflé Raises $135M to Push RNA Drug Into the Clinic Oct 16, 20267 min read Read the story Drugs & Biologics FDA Accepts First Keytruda Biosimilar for Review Oct 16, 20266 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 Drugs & Biologics MHRA Authorises Lilly's Weekly Insulin Onswik Oct 14, 20265 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 Drugs & Biologics AbbVie's Temab-A Wins Two FDA Breakthrough Tags Oct 13, 20265 min read Read the story For Physicians FDA Adds Tucatinib to HER2+ Breast Cancer Maintenance Oct 12, 20269 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 Spotlight TRexBio Raises $117M in Nasdaq IPO for Treg Drug 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 Drugs & Biologics FDA Approves Hovilpri for Drug-Resistant Herpes Lesions Oct 11, 20265 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 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 Drugs & Biologics FDA Approves Tucatinib Maintenance for HER2+ Cancer Oct 9, 20266 min read Read the story For Physicians MHRA Approves First Drug for Malignant Ascites Oct 8, 20269 min read Read the story Drugs & Biologics MHRA Approves Korjuny, a Revived Ascites Antibody Oct 8, 20266 min read Read the story Spotlight KymaThera Raises $80M to Advance Cancer Drug K-1728 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 Spotlight Trethera Lands Second Fast Track for Lung Cancer Drug 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 Drugs & Biologics Alvotech Wins FDA Nod to Double Simlandi Production 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 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 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 Spotlight AnaCardio Raises €62.5M to Fund Heart Drug Phase 2b Oct 1, 20266 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 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 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 Drugs & Biologics FDA Approves First-Ever Treatment for MCT8 Deficiency Sep 29, 20267 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 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 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 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 Spotlight Mirum Wins FDA Nod for Third FOP Drug Atebrioz Sep 26, 20266 min read Read the story Drugs & Biologics EU Approves First Drug for Cerebral ALD Sep 26, 20265 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 Drugs & Biologics MHRA Approves Lurbinectedin Combo for Lung Cancer Sep 25, 20265 min read Read the story Spotlight CHMP Recommends Zealand's Zeydovio for Bowel Disease Sep 24, 20266 min read Read the story Drugs & Biologics FDA Expands WINREVAIR Label With HYPERION Data 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 Drugs & Biologics CHMP Clears First mAb Biosimilar Under New EU Path Sep 22, 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 Spotlight RegCell Raises $66M for Nobel-Backed Treg Therapy 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 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 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 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 Spotlight Pharming Wins FDA Nod to Extend Joenja to Kids Sep 17, 20265 min read Read the story Drugs & Biologics TGA: Counterfeit Retatrutide Hid 8x-Dose Semaglutide Sep 16, 20265 min read Read the story Drugs & Biologics Cogent's Bezuclastinib Notches Third Simultaneous NDA Sep 16, 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 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 Drugs & Biologics FDA Clears Hyrnuo for First-Line HER2-Mutant Lung Cancer 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 Drugs & Biologics FDA Warns Alar Over Ads for Its Unapproved Ketamine Drug Aug 30, 20264 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 Drugs & Biologics FDA Approves Rasonque, First RAS-Targeted Cancer Drug Aug 26, 20265 min read Read the story Drugs & Biologics FDA Approves Ziihera Regimens for Gastric Cancer Aug 25, 20265 min read Read the story Drugs & Biologics EU Approves GSK's Twice-Yearly Asthma Drug Exdensur Aug 25, 20265 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 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 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 Guidance & Policy MHRA Clarifies UK Path for Microbiome Medicines 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 Drugs & Biologics FDA Grants Hearing on Generic Concerta After Decade Aug 16, 20265 min read Read the story Drugs & Biologics MHRA Approves Vimseltinib for Giant Cell Tumours Aug 15, 20264 min read Read the story Drugs & Biologics FDA Approves Bristol Myers' First CELMoD for Myeloma Aug 14, 20264 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 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 Drugs & Biologics FDA Approves First mRNA Flu Vaccine, Moderna's mFLUSIVA Aug 5, 20266 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 Guidance & Policy FDA Drafts Rules for Biosimilar Autoinjectors, Syringes 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 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 Drugs & Biologics MHRA Approves the World's First Low-Carbon Asthma Inhaler 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 Drugs & Biologics FDA Sets a September Hearing on Psychedelic Therapy Jul 16, 20265 min read Read the story Guidance & Policy FDA's OTC Monograph Meetings Guidance Is Final Jul 16, 20265 min read Read the story