FDA's long-standing accelerated approval program generally issues decisions in six months for drugs that treat life-threatening diseases. Regular drug reviews take about 10 months.

Lab-grown salmon is now FDA approved — here’s why this one restaurant is putting it on the menu By Caroline Cubbin Published June 10, 2025, 8:02 p.m. ET ...

George Medicines announced the FDA approval of its triple therapy polypill for initial treatment of adults with hypertension.The polypill (Widaplik) — formerly known as GMRx2 — contains three ...

FDA to offer faster drug reviews to companies promoting ‘national priorities’ by: MATTHEW PERRONE, Associated Press Posted: Jun 17, 2025 / 12:32 PM CDT Updated: Jun 17, 2025 / 12:32 PM CDT ...

Capricor Therapeutics (CAPR) announced the completion of the Food and Drug Administration’s pre-license inspection of its San Diego manufacturing facility for Deramiocel, the company’s lead ...

The U.S. Food and Drug Administration (FDA) approved Keytruda (pembrolizumab) for adults with resectable locally advanced head and neck squamous cell carcinoma that expresses PD-L1 (combined positive ...

Key Takeaways The FDA accepted Zepzelca plus Tecentriq for first-line maintenance in extensive-stage small cell lung cancer, granting priority review. Phase 3 IMforte trial showed Zepzelca plus ...

The FDA Is About to Weigh In. The agency is crafting a definition that could shape food policy nationwide. Listen to this article · 5:00 min Learn more Share full article ...

According to the FDA, all lots of the following products are included in the recall: Zicam Cold Remedy Nasal Swabs, with UPC 732216301205 Zicam Nasal AllClear Swabs, with UPC 732216301656 ...

The FDA has approved a new pill called Widaplik, which combines three drugs – telmisartan, amlodipine, and indapamide – to treat adults who have high blood pressure.

The FDA has approved Alcon’s acoltremon (Tryptyr) for signs and symptoms of dry eye disease. This is the first approval for an agonist of TRPM8, an ion channel that detects cold and menthol and ...