Regulatory Affairs

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

The growth round signals a push to move hospital imaging AI from triage to auto-drafted reports.

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

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

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

Peptide Craze Grows as HHS Chief Backs Wider Access

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

India Orders New Safety Warnings for Doxycycline and Carbimazole

FDA Rejects Moderna’s U.S. Filing for mRNA Flu Shot Over Trial Design

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

WHO Issues Global Alert on Indian Cough Syrups After 22 Child Deaths

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

Phase 3 Trial in Nature Medicine Finds Cannabis-Derived Drug Eases Chronic Low Back Pain

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

Gene Therapy Slows Huntington’s Progression by 75% in Three-Year Trial