FDA

Drug Approval Medical Devices Drug Shortages Drug Approval Process Compounded Drugs Hormonal Treatments Good Manufacturing Practices Drug Approvals Drug Recalls E-cigarette Products Drug Compounding FDA Approval

4 ARTICLES

3w ago

FDA Approves First Over-the-Counter Tylenol–Naproxen Combination Pill

The decision clears a single-dose, 12-hour non-opioid pain option and may block direct copycat products for up to three years under an exclusivity claim.

6 ARTICLES

2mo ago

More Than 370,000 Duloxetine Bottles Recalled Over Nitrosamine Contamination

6 ARTICLES

5mo ago

FDA Demands Placebo-Controlled Trial for UniQure’s Huntington’s Gene Therapy

3 ARTICLES

5mo ago

FDA Warns 30 Telehealth Firms Over Misleading Ads for Compounded GLP-1 Weight-Loss Drugs

3 ARTICLES

11mo ago

Chinese Weight-Loss Drug Suppliers Pivot to Generics as U.S. Crackdown Ends Copycat Boom