Regulatory Affairs

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FDA Staff Flags Major Flaws in Capricor’s Deramiocel Data

An independent advisory committee will decide on July 29 whether the trial evidence gives regulators enough reason to approve the cell therapy.

Aidoc Raises $150 Million to Scale FDA-Cleared Imaging AI Platform

Gilead Closes $7.8 Billion Arcellx Deal to Take Full Control of Anito‑cel

Clearmind’s AUD Candidate Meets Early Safety Goal as Shares Double

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

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

Daré Bioscience Launches Topical Sildenafil Cream for Female Arousal

Dyne’s DMD Drug Hits Primary Endpoint in DELIVER REC, Shows Functional Gains

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

Bayer Stroke Drug Asundexian Hits Phase III Goals, Shares Jump

Agios’ Sickle Cell Pill Lifts Hemoglobin but Misses Pain-Crisis Goal in Phase 3

Cannabis Extract VER-01 Eases Chronic Low Back Pain in Phase 3 Trial

FDA Approves Palsonify, First Once-Daily Oral Treatment for Acromegaly

EU Regulators Back Uplizna as First Treatment for IgG4‑Related Disease

CSL Secures VarmX Acquisition Option, Funding Phase 3 of Factor Xa Reversal Drug

FDA Approves First New Fibromyalgia Treatment in 15 Years

Hims & Hers Plans Canadian Launch of Generic Semaglutide After Zava Acquisition