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Explore the medicines, devices and technologies we cover. Six sectors. The latest reporting behind each.
Explore the directoryReporting from the primary record.
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Showing all 38 categories
Pharmaceuticals
Medicines, formulations and the evidence behind approval.
8 product categories
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60 stories
Biologics
Proteins, antibodies, vaccines and plasma products, licensed through a BLA or an EU marketing authorisation.
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7 stories
Biosimilars
Follow-on biologics approved on comparability to a reference product rather than on a full dossier.
Latest reportingXbrane Wins FDA Nod for Lucamzi Eye BiosimilarView all 7 stories
- Xbrane Wins FDA Nod for Lucamzi Eye Biosimilar
- FDA Accepts First Keytruda Biosimilar for Review
- FDA Finalizes Biosimilar Manufacturing-Change Rules
- Alvotech Wins FDA Nod to Double Simlandi Production
- FDA Approves Teva's Denosumab Biosimilar to Xgeva
- CHMP Clears First mAb Biosimilar Under New EU Path
- FDA Drafts Rules for Biosimilar Autoinjectors, Syringes
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3 stories
Inhalation & Nasal Drug Products
Inhalers, nebulised products and nasal sprays, where device and drug are reviewed together.
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17 stories
Injectable Therapies
Parenteral products and the autoinjectors, pens and prefilled syringes that deliver them.
Latest reportingFDA Revises Its Drug-Delivery Device Test GuidanceView all 17 stories
- FDA Revises Its Drug-Delivery Device Test Guidance
- FDA Warns Baxter Over Repeat Sterile-Plant Failures
- FDA Approves Subcutaneous-Only Skyrizi Induction
- FDA Approves At-Home SKYRIZI Start for Crohn's
- FDA Approves Autoinjector for UCB's Zilbrysq
- FDA Approves Enspryng, First At-Home Thyroid Eye Drug
- FDA Approves Enspryng as First At-Home TED Treatment
- FDA Approves Teva's Weltruza for Schizophrenia
- Par Health Recalls Brevital Sodium Over Cellulose
- FDA Recall: Compounded Glutathione Tied to ED Visits
- FDA Clears AI to Quantify Liver, Visceral Fat on MRI
- FDA Hits Fresenius Kabi With Second Warning Letter
- CHMP Recommends Zealand's Zeydovio for Bowel Disease
- EMA Reviews Injectable Iron Drugs Over Bone-Risk Reports
- FDA Clears LEROCHOL Autoinjector, Adds CV Risk Claim
- FDA Drafts Rules for Biosimilar Autoinjectors, Syringes
- FDA Approves MannKind's 10-Second Heart-Failure Autoinjector
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10 stories
Oral Solid Dosage Forms
Tablets and capsules, and the bioequivalence and dissolution questions that follow them.
Latest reportingFDA Widens Olympus Import Alert to GI ScopesView all 10 stories
- FDA Widens Olympus Import Alert to GI Scopes
- FDA Approves Autoinjector for UCB's Zilbrysq
- Zydus Launches First Generic Adempas Rival in the US
- CapsoVision Clears FDA for AI-Assisted Capsule Endoscopy
- FDA Recalls Vitruvias Thyroid Tablets Over Superpotency
- FDA Issues 55 New Bioequivalence Guidances for Generics
- FDA Revises Guidance on ANDA vs. 505(b)(2) Filings
- FDA Grants Hearing on Generic Concerta After Decade
- FDA Finalizes Adhesion Rules for Generic Skin Patches
- FDA Retires a 1995 Guidance on Topical Steroids
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17 stories
Small Molecule Drugs
Chemically synthesised medicines, reviewed through the NDA, ANDA and 505(b)(2) routes.
Latest reportingFDA Tentatively Approves First Generic HIV-Prevention ShotView all 17 stories
- FDA Tentatively Approves First Generic HIV-Prevention Shot
- NRx Pharmaceuticals Secures FDA Nod for Ketamine Drug
- FDA Approves First Generic Combined Menopause Patch
- Cosette Earns Its First FDA Drug Approval With EVOXAC
- FDA Extends Orladeyo Pellets to Patients 12 and Up
- Opus Genetics Wins Second FDA Nod for RYZUMVI
- Zydus Launches First Generic Adempas Rival in the US
- Cogent's Bezuclastinib Notches Third Simultaneous NDA
- FDA Approves Telix's Pixclara for Glioma Imaging
- FDA Issues 55 New Bioequivalence Guidances for Generics
- FDA Finalizes Guidance on Generic Drug TE Codes
- FDA Revises Guidance on ANDA vs. 505(b)(2) Filings
- FDA's GDUFA IV Plan Would Raise Foreign Drug Fees
- FDA Grants Hearing on Generic Concerta After Decade
- UK First in Europe to Approve Lilly's Foundayo Pill
- FDA Finalizes Adhesion Rules for Generic Skin Patches
- FDA Retires a 1995 Guidance on Topical Steroids
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10 stories
Topical & Transdermal Products
Creams, gels and patches, where delivery through skin is the review question.
Latest reportingFDA Narrows Menopause Hormone Therapy's Boxed WarningView all 10 stories
- FDA Narrows Menopause Hormone Therapy's Boxed Warning
- FDA Eases Boxed Warning on 3 More Estrogen Patches
- FDA Approves First Generic Combined Menopause Patch
- Wellysis Wins FDA Clearance for S-Patch CardioAI
- Quoin Wins First-Ever Fast Track for Peeling Skin Syndrome
- FAYUVI's Label Limits It to Early-Stage Sanfilippo
- Beta Bionics Wins FDA Clearance for Mint Patch Pump
- FDA Grants Nutromics' Patch Breakthrough Status
- FDA Finalizes Adhesion Rules for Generic Skin Patches
- FDA Retires a 1995 Guidance on Topical Steroids
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8 stories
Vaccines
Prophylactic and therapeutic vaccines, their strain changes and their advisory committees.
Latest reportingNuravax Wins FDA Fast Track for Alzheimer's VaccineView all 8 stories
- Nuravax Wins FDA Fast Track for Alzheimer's Vaccine
- EMA, African Regulators Set Rules for Ebola Trials
- Nouscom Raises $135M for Cancer-Prevention Vaccine
- FDA Advisers Back 2027 Flu Vaccine Strains, 9-0
- FDA Nominee Overton Grilled on Mifepristone, Vaccines
- FDA Approves Fall 2026 COVID Shots, Keeps Narrow Use
- FDA Approves First mRNA Flu Vaccine, Moderna's mFLUSIVA
- CHMP Backs the EU's First Refillable Eye Implant
Medical Devices
The systems and instruments changing how care is delivered.
8 product categories
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7 stories
Drug Delivery Systems
Pumps, infusion sets and delivery devices regulated with the product they administer.
Latest reportingFDA Revises Its Drug-Delivery Device Test GuidanceView all 7 stories
- FDA Revises Its Drug-Delivery Device Test Guidance
- FDA Clears Twiist Pump for Type 2 Diabetes
- FDA Flags Edwards SAPIEN M3 Delivery System After Death
- TriSalus Wins FDA Clearance for TriNav Advance
- Beta Bionics Wins FDA Clearance for Mint Patch Pump
- FDA Finalizes Adhesion Rules for Generic Skin Patches
- CHMP Backs the EU's First Refillable Eye Implant
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16 stories
Imaging Systems
CT, MRI, ultrasound and radiographic systems, and the software read alongside them.
Latest reportingFDA Sets a Class II Path for Spinal-Imaging DevicesView all 16 stories
- FDA Sets a Class II Path for Spinal-Imaging Devices
- X9 Wins Second FDA Nod for Dialysis Needle Guidance
- Deep Reasoning AI Secures FDA Clearance for NeuroDR
- RIVANNA Wins FDA Clearance for BoneEnhance AI
- NeuroXT Clears FDA for Alzheimer's Risk AI Tool
- FDA Clears AI Tool to Score Breast Cancer Recurrence
- SimBioSys Earns FDA Clearance for TumorSight Risk
- FDA Links Philips Lumify Ultrasound Bug to Four Deaths
- MRI2CT Clears FDA Hurdle for AI Spine Imaging
- FDA Clears AI to Quantify Liver, Visceral Fat on MRI
- AIRS Medical Clears FDA 510(k) for Body-Fat MRI AI
- UltraSight Raises $24M to Scale AI Cardiac Ultrasound
- Koning Health Wins TGA Approval for Breast CT System
- FDA Approves Telix's Pixclara for Glioma Imaging
- FDA Posts First Two Warning Letters Under New QMSR
- FDA Lets Proscia Add Scanners Without New 510(k)s
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22 stories
Implantable Devices
Devices placed in the body — valves, leads, stimulators, orthopaedic implants.
Latest reportingFDA Flags ButterflyBVM Resuscitators Over Bellows HolesView all 22 stories
- FDA Flags ButterflyBVM Resuscitators Over Bellows Holes
- CHMP Backs Second Achondroplasia Drug, Dosed Weekly
- FDA Clears Edwards' Pascal for Tricuspid Repair
- Gore Wins FDA Nod for First On-Label Bridging Stent
- FDA Flags Edwards SAPIEN M3 Delivery System After Death
- icotec Wins Medicare Add-On Payment for CMORE CT
- Zenflow Lands $52M Series D, Cook Medical Distribution
- FDA Approves First Expandable Pulmonary Valve for Kids
- CMS Ends TAVR's Mandatory Two-Operator Rule
- FDA Clears SI-BONE Implant for Fusion Screw Loosening
- Xenix Medical Clears FDA for Riva Anchor SI Implant
- France Pulls Getinge Vascular Grafts Over Yarn Defect
- HighLife Raises $90M for US Valve Trial, EU Growth
- FDA Approves Cordis' Sirolimus-Eluting Balloon
- Dialybrid Raises €15M, Implants First Vascular Graft
- Shoulder Innovations Clears FDA Hurdle for N-22 Implant
- Emboline Clears FDA Hurdle for TAVR Debris Filter
- MHRA Flags Wear Risk in Five Modular-Neck Hip Implants
- Boston Scientific Cyberattack Halts Device Shipments
- FDA Clears BlueWind's Revi Extend Bladder Implant
- FDA Clears Sight Sciences' OMNI Ultra for Glaucoma
- CHMP Backs the EU's First Refillable Eye Implant
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8 stories
Patient Monitoring Systems
Bedside and ambulatory monitors, and the alarms and signals regulators inspect.
Latest reportingMonebo Clears FDA for Kinetic ECG Software LibraryView all 8 stories
- Monebo Clears FDA for Kinetic ECG Software Library
- HeartBeam Wins FDA Breakthrough Status for Heart Attacks
- Wellysis Wins FDA Clearance for S-Patch CardioAI
- FDA Clears Tempus AI Tool to Flag Mitral Regurgitation
- Powerful Medical Wins First FDA Nod for AI-ECG Tool
- FDA Clears Tempus's AI Tool for Pulmonary Hypertension
- MHRA Flags Ventilator Failure Risk in Dräger Atlan Units
- FDA Classifies Ventilator, Heart-Pump Recalls as Class I
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9 stories
Robotics
Robotic surgical and interventional systems, and the human-factors case behind them.
Latest reportingMedical Microinstruments Lands $125M for SymaniView all 9 stories
- Medical Microinstruments Lands $125M for Symani
- FDA's CDRH Flags AI and Surgical Robots for FY2027
- CapsoVision Clears FDA for AI-Assisted Capsule Endoscopy
- FDA Drafts First Guidance for Surgical Robots
- FDA Clears Neptune Medical's Robotic Endoscope
- FDA Clears First Robotic LigaSure Vessel Sealer
- FDA Breakthrough Status for Remote Robotic Stroke Device
- FDA Clears Spineart's Robotic Spine Screw App
- FDA Authorizes First Robotic Blood-Draw Device
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3 stories
Sterile & Single-Use Devices
Single-use instruments and sterile barriers, where sterilisation and reprocessing decide the file.
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26 stories
Surgical Systems
Operating-theatre systems — energy devices, staplers, navigation and the instruments around them.
Latest reportingFDA Approves Voceryq, a DNA Immunotherapy for RRPView all 26 stories
- FDA Approves Voceryq, a DNA Immunotherapy for RRP
- CHMP Backs Second Achondroplasia Drug, Dosed Weekly
- FDA Approves Second Device for Tricuspid Repair
- FDA Clears Lightning CAVT for Deep Vein Thrombosis
- Solventum Clears FDA to Pair Two Wound Therapies
- FDA Approves First Immunotherapy for Rectal Cancer
- FDA Clears Urolution OpenFlo Urinary Catheter
- FDA Approves First Spiral-Optic Presbyopia Lens
- Medical Microinstruments Lands $125M for Symani
- MRI2CT Clears FDA Hurdle for AI Spine Imaging
- TELA Bio Wins FDA Clearance for Liora Mesh
- FDA's Camzyos Teen Label Requires CYP2C19 Testing
- Medtronic Wins FDA Breakthrough Tag for Below-Knee PAD
- FDA's CDRH Flags AI and Surgical Robots for FY2027
- FDA Approves First Expandable Pulmonary Valve for Kids
- FDA Clears Medtronic's Affera Prism-2 Mapping Software
- CMS Ends TAVR's Mandatory Two-Operator Rule
- FDA Clears SI-BONE Implant for Fusion Screw Loosening
- Route 92 Medical Clears FDA for FreeClimb 46
- FDA Drafts First Guidance for Surgical Robots
- TriSalus Wins FDA Clearance for TriNav Advance
- FDA Clears First Robotic LigaSure Vessel Sealer
- FDA Breakthrough Status for Remote Robotic Stroke Device
- MHRA Flags Wear Risk in Five Modular-Neck Hip Implants
- FDA Clears Spineart's Robotic Spine Screw App
- MHRA Warns Against Infant Gas-Relief Catheters
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6 stories
Wearables
Body-worn sensors and therapeutics, from continuous monitors to wearable rings and patches.
Digital Health
Software, connected care and the algorithms entering clinical practice.
8 product categories
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9 stories
Artificial Intelligence (AI/ML)
Machine-learning devices, predetermined change control plans and the generative-AI question.
Latest reportingRIVANNA Wins FDA Clearance for BoneEnhance AIView all 9 stories
- RIVANNA Wins FDA Clearance for BoneEnhance AI
- MHRA Publishes Strategy 2030 for the AI Era
- FDA's CDRH Flags AI and Surgical Robots for FY2027
- FDA Denies Bid to Exempt Radiology AI From 510(k)
- Beta Bionics Wins FDA Clearance for Mint Patch Pump
- FDA Names Permanent CDER, CBER Chiefs, New AI Post
- FDA Clears Tempus's AI Tool for Pulmonary Hypertension
- FDA Weighs a Competency Test for AI Medical Devices
- FDA Lets Proscia Add Scanners Without New 510(k)s
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Awaiting coverage
Clinical Decision Support (CDS)
Software that informs a clinician’s judgement, and where the line of enforcement discretion falls.
On our radar. Reporting will appear here as this category develops.
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Awaiting coverage
Connected Medical Devices
Networked devices, their interoperability and the post-market surveillance the connection creates.
On our radar. Reporting will appear here as this category develops.
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2 stories
Cybersecurity
Premarket cyber documentation, SBOMs and the vulnerability disclosures that follow a device to market.
Latest reportingFDA Drafts First Guidance for Surgical Robots -
2 stories
Digital Therapeutics (DTx)
Software that treats a condition, cleared on clinical evidence rather than on claims.
Latest reportingUltragenyx Sells Priority Review Voucher for $210M -
Awaiting coverage
Mobile Medical Applications
Apps that are devices, and the guidance that decides which of them are.
On our radar. Reporting will appear here as this category develops.
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Awaiting coverage
Remote Patient Monitoring (RPM)
Monitoring outside the clinic, and the reimbursement and safety questions it raises.
On our radar. Reporting will appear here as this category develops.
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2 stories
Software as a Medical Device (SaMD)
Software that is itself the device, classified on the seriousness of the decision it drives.
Latest reportingWellysis Wins FDA Clearance for S-Patch CardioAI
Advanced Therapies
Cell, gene and tissue-based approaches to treatment.
4 product categories
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2 stories
Cell Therapy
Cell-based products, from CAR-T to stem-cell therapies, and their RMAT and CAT routes.
Latest reportingAspen Neuroscience Prices $140.6M Nasdaq IPO -
13 stories
Gene Therapy
Vectors and gene editing, their long-term follow-up and their accelerated approvals.
Latest reportingFDA Accepts First Gene Therapy for Huntington'sView all 13 stories
- FDA Accepts First Gene Therapy for Huntington's
- Specific Biologics Raises $35M for ALS Gene Editor
- FDA Finalizes Potency Guidance for Cell, Gene Therapies
- MHRA Lowers Casgevy's Age Floor to Five; FDA's Is Two
- MHRA Extends Casgevy Gene Therapy to Children Aged Five
- FDA Drafts a Path to One BLA Per Gene-Editing Family
- Estuary Launches With $103M for Kidney Gene Therapy
- Ultragenyx Sells Priority Review Voucher for $210M
- FAYUVI's Label Limits It to Early-Stage Sanfilippo
- Cyllene Wins FDA RMAT Status for Bladder Gene Therapy
- FDA Approves First Gene Therapy for Sanfilippo Type A
- FDA Finalizes FAQ Guide for Cell, Gene Therapies
- FDA Approves First Gene Therapy for GSDIa
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2 stories
Regenerative Medicine
Products that restore function, and the RMAT designation written for them.
Latest reportingAspen Neuroscience Prices $140.6M Nasdaq IPO -
2 stories
Tissue-Engineered Products
Engineered tissue and scaffolds, reviewed where biologic and device rules meet.
Diagnostics
Tests, platforms and the evidence that guides clinical decisions.
4 product categories
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7 stories
Companion Diagnostics
Tests that select a therapy, approved alongside the drug they are tied to.
Latest reportingFDA Moves a Targeted Combo Earlier in Prostate CancerView all 7 stories
- FDA Moves a Targeted Combo Earlier in Prostate Cancer
- FDA Expands Talzenna-Xtandi to Earlier Prostate Cancer
- FDA Approves Hibsago, First Antisense Hepatitis B Drug
- FDA Narrows Pembrolizumab's TMB-High Cancer Approval
- FDA Approves Oral SERD Combo for ESR1+ Breast Cancer
- FDA Approves Lilly's Inluriyo-Verzenio Combo
- FDA Eases Path for Cancer Companion Diagnostics
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10 stories
In Vitro Diagnostics (IVD)
Laboratory tests under the IVDR and the US framework, including laboratory-developed tests.
Latest reportingElement Biosciences Launches CE-Marked AVITI DxView all 10 stories
- Element Biosciences Launches CE-Marked AVITI Dx
- Roche Wins CE Mark for cobas smart e Immunoanalyser
- UK Confirms Indefinite Recognition of CE-Marked Devices
- WHO Expands Device Prequalification to Condoms, IUDs
- EU's IVDR Class C Notified-Body Deadline Passes
- UpFront Diagnostics Earns CE Mark for Stroke Test
- FDA Clarifies Path for Spectral's Sepsis Device
- Brussels Says Only Manufacturers May Assign a Device's UDI
- FDA Retires a 1995 Guidance on Topical Steroids
- EUDAMED's Next Deadline Is Narrower Than It Looks
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4 stories
Molecular Diagnostics
Nucleic-acid and sequencing-based tests, and the evidence their claims rest on.
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2 stories
Point-of-Care Diagnostics
Tests run where the patient is, including over-the-counter and CLIA-waived formats.
Emerging Technology
New materials and technologies at the boundaries of regulation.
6 product categories
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Awaiting coverage
3D Printing
Additive manufacturing of devices, including point-of-care production.
On our radar. Reporting will appear here as this category develops.
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Awaiting coverage
Biomaterials
Materials in contact with the body, and the biocompatibility evidence they need.
On our radar. Reporting will appear here as this category develops.
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2 stories
Combination Products
Drug-device and biologic-device combinations, and which centre leads the review.
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Awaiting coverage
Nanotechnology
Nanomaterials and nanoscale delivery, where characterisation carries the file.
On our radar. Reporting will appear here as this category develops.
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1 story
Precision Medicine
Therapies and tests matched to a patient’s biology, and the biomarker evidence behind them.
Latest reportingMHRA Publishes Strategy 2030 for the AI Era -
Awaiting coverage
Smart Materials
Materials that respond to their environment — shape-memory, stimuli-responsive and self-healing.
On our radar. Reporting will appear here as this category develops.
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A map of our coverage.
Regulatory News tracks 38 product categories across 6 sectors. 30 categories have published coverage, with 209 unique stories between 15 July 2026 and 5 November 2026. Reporting is sourced to primary records and edited by Connor Griggs. Last updated 5 November 2026.
Categories overlap: a connected monitor can also be a medical device and a software product. Stories may appear in more than one category; the story total counts each once.
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