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uniQure Shares Plummet After AMT-130 Misses Pre-Specified Statistical Goal

Citing possible control-group attrition bias, uniQure is relying on a stronger 36-month dataset in its FDA filing.

FDA Advisory Panel Reviews GRAIL’s Galleri Multi‑Cancer Blood Test

Capricor Hit with Multiple Investor Lawsuits After FDA Questions Unagreed Trial Analysis

Capricor Faces Securities Class Action as FDA Extends Review of Duchenne Therapy

Ultra Violette Launches First U.S. Sunscreen With Newly Approved Filter

Nearly 40,000 Clear Eyes Bottles Recalled Over Sterility Concerns

FDA Authorizes Four Flavored Nicotine Pouches as Health Groups Raise Alarms

Moderna Posts Q2 Revenue Beat as Norovirus Trial Misses Interim Goal

FDA Advisory Panel Recommends Six Peptides for Pharmacy Compounding

FDA Staff Flags Major Flaws in Capricor’s Deramiocel Data

FDA Advisers Recommend BPC-157 for Pharmacy Compounding

Kalshi Opens Betting Markets for Phase 3 Drug Trials and FDA Decisions

FDA Says Metals Found in Tampons Are Not at Harmful Levels

FDA Authorizes Zyn to Market Reduced‑Risk Claims for 20 Nicotine Pouch Products

FDA Allows Zyn to Be Marketed as Lower Risk Than Cigarettes

Youth Tobacco Use Falls to Multi-Year Low, But Vaping and Pouches Keep Risks High

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

FDA Adds Bemotrizinol to U.S. Sunscreen Ingredients, First New Filter in Over 20 Years

FDA Adds Bemotrizinol to U.S. Sunscreen Ingredients

FDA Clears Tempus xT CDx to Run as Tumor‑Only Diagnostic