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Drug Approval Process Vaccine Approval Process Drug Safety Drug Approval Drug Recalls New Drug Application Biologics License Application Drug Approval Processes Priority Review Fast Track Designation

FDA Approves Orzeyful, First Orexin-Receptor Activator for Narcolepsy Type 1

The oral twice-daily pill is designed to restore orexin signaling and treat the full range of symptoms in adults.

Eli Lilly Opens Limited Early Access to Experimental Obesity Drug Retatrutide

Nearly 12 Million Rohto Eye Drop Cartons Recalled Over Sterility Concerns

FDA Advisers Find Replimune’s RP1 Trial Results Clinically Meaningful

FDA Panel Rejects Deramiocel Cardiac Claim After Lancet Publishes HOPE‑3 Results

Dupixent Surge Lets Sanofi Reset Strategy as Regeneron Posts Strong Quarter

Major Rugby Recalls 12 Batches of Levothyroxine Nationwide

MapLight’s Schizophrenia Candidate Posts Mixed Phase II Results as Shares Plummet

FDA Staff Flags Major Flaws in Capricor’s Deramiocel Data

Manufacturer Recalls Generic Zyrtec Over Possible Ranitidine Contamination

FDA Grants Priority Review to Pfizer’s Talzenna Plus Xtandi for HRR-Altered mCSPC

FDA Scientists Say Evidence Lacks for Allowing Seven Popular Peptides in Compounding

Regulators Move to Strip Approval of Tavneos After Trial Misconduct and Liver Safety Signals

FDA Grants Priority Review to Roche’s Enspryng for Thyroid Eye Disease

FDA Classifies Chlorthalidone Recall as Class II

Nationwide Recall of 25 mg Chlorthalidone Covers 11,460 Bottles

FDA Agrees Three‑Year Phase I/II Data Can Support uniQure’s AMT‑130 Accelerated BLA

FDA Panel Weighs Moderna’s Bid for First U.S. mRNA Flu Vaccine

More Than 370,000 Duloxetine Bottles Recalled Over Nitrosamine Contamination

FDA Clears Dexcom Stelo as First OTC CGM for Children