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FDA

Drug Approval Process Vaccine Approval Process Drug Approval Drug Safety Drug Recalls Biologics License Application New Drug Application Product Recalls Advisory Committees Drug Approval Processes

FDA Elevates Inventia Chlorthalidone Recall to Class II After Failed Dissolution Tests

The designation signals moderate health risk and has prompted nationwide lot checks and advice for patients and pharmacists to verify supplies.

FDA Advisory Panel Backs Grail’s Galleri Blood Test but Flags Key Evidence Gaps

FDA Elevates Vitruvias Thyroid Tablet Recall to Class I

FDA Asks Drugmakers for More Data on Testosterone Use in Menopausal Women

Houston Compounder Recalls Injectable Wellness Products Over Endotoxin Contamination

Company Recalls Three Lots of Multi‑Dose Epinephrine Vials Over Contamination Concerns

FDA Works With Manufacturers to Expand Supply of Estradiol Menopause Patches

FDA Approves Lisraya as First Oral Treatment for Adult Dermatomyositis

FDA Clears Libre Duo 10 Day as First Wearable to Track Ketones and Glucose

Vitruvias Recalls Lot of Thyroid Tablets Over 'Superpotent' Test Results

FDA Places Clinical Hold on REGENXBIO's RGX‑121 After Spine MRI Findings

Nearly 40,000 Clear Eyes Bottles Recalled Over Sterility Concerns

Almost All FDA‑Cleared Medical AI Lack Evidence They Help Patients

Amylyx’s Avexitide Cuts Moderate‑to‑Severe Post‑Bariatric Hypoglycemia Events 55% in Phase 3

Cold Platelets Stored Up to 21 Days Are Clinically Noninferior in Cardiac Surgery

FDA Approves Orzeyful as First Orexin Agonist for Narcolepsy Type 1

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