Coverage

FDA

Every FDA story we’ve published, newest first — each one sourced to the primary record.

All coverage

63 stories

FDA

FDA Approves Fall 2026 COVID Shots, Keeps Narrow Use

Aug 30, 20265 min read

FDA

FDA Warns Alar Over Ads for Its Unapproved Ketamine Drug

Aug 30, 20264 min read

FDA

FDA Authorizes New JUUL2 E-Cigarette System

Aug 28, 20265 min read

Clinical

FDA Approves First Drug for Polycythemia Vera

Aug 28, 20264 min read

Clinical

FDA Approves First Oral Drug for Dermatomyositis

Aug 27, 20265 min read

Devices

FDA Clears Spineart’s Robotic Spine Screw App

Aug 26, 20264 min read

FDA

FDA Approves Rasonque, First RAS-Targeted Cancer Drug

Aug 26, 20265 min read

Devices

FDA Clears Abbott’s Libre Duo Glucose-Ketone Monitor

Aug 25, 20265 min read

FDA

FDA Approves Ziihera Regimens for Gastric Cancer

Aug 25, 20265 min read

Devices

FDA Clears Masimo’s Root With LiDCO for Oxygen Delivery

Aug 25, 20264 min read

Devices

FDA Clears Tempus’s AI Tool for Pulmonary Hypertension

Aug 25, 20264 min read

Guidance

FDA Issues 55 New Bioequivalence Guidances for Generics

Aug 25, 20265 min read

FDA

FDA Extends Review of Capricor’s Duchenne Therapy

Aug 24, 20265 min read

Devices

FDA Classifies Enroute Carotid Recall as Class I

Aug 24, 20265 min read

Devices

FDA Recognizes 14 Updated Medical Device Standards

Aug 24, 20265 min read

Guidance

FDA Finalizes Guidance on Generic Drug TE Codes

Aug 23, 20266 min read

FDA

FDA Finalizes FAQ Guide for Cell, Gene Therapies

Aug 23, 20266 min read

Guidance

FDA Revises Guidance on ANDA vs. 505(b)(2) Filings

Aug 20, 20265 min read

Clinical

FDA Approves First Gene Therapy for GSDIa

Aug 20, 20266 min read

Devices

FDA Authorizes First Robotic Blood-Draw Device

Aug 20, 20266 min read

FDA

FDA Eases Path for Cancer Companion Diagnostics

Aug 19, 20265 min read

Devices

FDA Weighs a Competency Test for AI Medical Devices

Aug 19, 20265 min read

FDA

FDA Clears LEROCHOL Autoinjector, Adds CV Risk Claim

Aug 18, 20265 min read

Manufacturing

FDA’s GDUFA IV Plan Would Raise Foreign Drug Fees

Aug 18, 20265 min read

Devices

FDA Sets a September Panel on GRAIL’s Galleri Blood Test

Aug 17, 20266 min read

Manufacturing

FDA Flags Novo Nordisk’s Indiana Plant as Highest Risk

Aug 17, 20266 min read

Guidance

FDA Sets September Meeting on PDUFA VIII Fee Deal

Aug 16, 20265 min read

Devices

FDA Grants Breakthrough Status to Freenome Lung Test

Aug 16, 20265 min read

Manufacturing

FDA Grants Hearing on Generic Concerta After Decade

Aug 16, 20265 min read

Guidance

FDA Drafts New Guidance on Drug Container Closures

Aug 15, 20265 min read

Guidance

FDA Widens Type D Meetings, Narrows INTERACT Use

Aug 14, 20265 min read

FDA

FDA Approves Bristol Myers’ First CELMoD for Myeloma

Aug 14, 20264 min read

Manufacturing

FDA Posts First Two Warning Letters Under New QMSR

Aug 13, 20266 min read

FDA

FDA Warns Investigator Over Trial Drug Accountability

Aug 13, 20265 min read

Devices

FDA Lets Proscia Add Scanners Without New 510(k)s

Aug 6, 20265 min read

Devices

FDA Clears Sight Sciences’ OMNI Ultra for Glaucoma

Aug 4, 20265 min read

Manufacturing

FDA Launches Council to Overhaul Its Inspections

Aug 3, 20266 min read

FDA

FDA Approves Replimune’s Twice-Rejected Melanoma Drug

Aug 6, 20266 min read

FDA

FDA Approves Takeda’s Orzeyful for Narcolepsy Type 1

Aug 5, 20264 min read

FDA

FDA Approves First mRNA Flu Vaccine, Moderna’s mFLUSIVA

Aug 5, 20266 min read

Devices

FDA Clears BlueWind’s Revi Extend Bladder Implant

Aug 5, 20265 min read

Devices

FDA Classifies Ventilator, Heart-Pump Recalls as Class I

Aug 3, 20265 min read

FDA

FDA Reopens Comment Period on Title 21 Terminology Rule

Aug 3, 20264 min read

Guidance

FDA Drafts Rules for Biosimilar Autoinjectors, Syringes

Aug 3, 20265 min read

FDA

FDA Debars Research Site Owners Who Faked Trial Data

Aug 3, 20265 min read

FDA

FDA Grants Breakthrough Status to Lilly’s KRAS Drug

Aug 3, 20264 min read

FDA

FDA Panel Votes 9-3 Against Capricor’s DMD Heart Drug

Aug 2, 20266 min read

FDA

FDA Licenses the First Freeze-Dried Plasma for the US

Aug 2, 20265 min read

Guidance

FDA Finalizes Adhesion Rules for Generic Skin Patches

Aug 2, 20265 min read

Guidance

FDA Finalizes Three Cancer Trial Eligibility Guidances

Jul 30, 20265 min read

Devices

FDA Gives Home COVID Tests a Permanent Class II Address

Jul 27, 20265 min read

FDA

FDA Approves MannKind’s 10-Second Heart-Failure Autoinjector

Jul 27, 20265 min read

FDA

FDA’s Cell Therapy Panel Revisits a Once-Rejected DMD Drug

Jul 26, 20266 min read

Manufacturing

FDA Publishes Its Playbook for Fast-Track CMC Readiness

Jul 26, 20265 min read

Devices

FDA Picks Dexcom as First TEMPO Pilot Participant

Jul 24, 20266 min read

FDA

FDA Sets a July 30 Panel on Replimune’s Melanoma Drug

Jul 17, 20265 min read

FDA

FDA Can Now Ask the Public for OTC Monograph Data

Jul 17, 20265 min read

Guidance

FDA Retires a 1995 Guidance on Topical Steroids

Jul 17, 20265 min read

Devices

MDUFA VI: The Draft Deal Is Out, With a Faster 510(k) Clock

Jul 16, 20266 min read

FDA

FDA Sets a September Hearing on Psychedelic Therapy

Jul 16, 20265 min read

FDA

FDA Would Let Distributed Manufacturers Register Once

Jul 16, 20266 min read

Guidance

FDA’s OTC Monograph Meetings Guidance Is Final

Jul 16, 20265 min read

FDA

FDA’s Psychedelics Guidance Is Final, After Three Years

Jul 15, 20265 min read