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FDA

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

A 9–3 advisory vote and critical FDA reviews increase doubt about final approval ahead of the August 22 PDUFA date.

FDA Staff Flags Major Flaws in Capricor’s Deramiocel Data

Fulcrum Halts Pociredir Development After FDA Flags PRC2 Cancer Risk

Theriva’s VCN-01 Extends Survival in Phase 2b Pancreatic Cancer Trial, Paving Way to Phase 3

Peptide Craze Grows as HHS Chief Backs Wider Access

FDA Upgrades Children’s Ibuprofen Recall to Class II Over Reports of Foreign Material

Novo Nordisk Strikes Hims & Hers Deal for Ozempic and Wegovy, Drops Patent Suit

FDA Recalls Specific FreeStyle Libre 3 Sensors Over Faulty Low-Glucose Readings

Sarepta Reports 3-Year EMBARK Data Showing Elevidys Slows Duchenne Progression

Bristol Myers Delays ADEPT-2 Alzheimer’s Psychosis Readout to 2026 After Site Irregularities

Wawa Recalls Select 16-Ounce Milk and Lemonade Sold in 4 States

Sarepta Shares Plummet on FDA Review of Elevidys Following Third Patient Death

FDA Warns of Rare Severe Itching After Stopping Common Allergy Medications