FDA Related News

Medical Devices

Hologic BioZorb Marker Recall Class 1: FDA

FDA says a Hologic 3/2024 recall correction of BioZorb Markers was Class 1.

Human Drugs

UCB Minzasolmin Parkinsons Study Misses Endpoints

UCB says it is ending the development of minzasolmin, a drug it was working on with Novartis to treat early Parkinsons disease, after the drug missed ...

Medical Devices

FDA Alert on Baxter Solution Sets

FDA issues an alert against the use of certain Baxter Solution Sets with Duo-Vent Spikes because they were incorrectly assembled with inverted slide c...

Human Drugs

CRL for Zealands SBS Treatment NDA

FDA issues a complete response letter for Zealands glepaglutide intended to treat short bowel syndrome.

Human Drugs

Quality, Data Issues at Mylan Facility in India

FDA warns a Viatris Mylan drug manufacturing facility in Pradesh, India, about CGMP violations involving quality and data issues.

Human Drugs

Boxed Warning for Veozah Liver Injury

FDA adds a liver injury Boxed Warning to labeling for Astellas menopause hot flash drug Veozah.

Human Drugs

Sombra Cosmetics CGMP Violations

FDA warns Albuquerque, NM-based Sombra Cosmetics about CGMP violations in the manufacturing of finished drugs.

Human Drugs

FDA OKs Mesoblasts Ryoncil Cell Therapy

FDA approves Mesoblasts Ryoncil to treat some graft-versus-host disease pediatric patients.

Human Drugs

Lexicon Dropping Zynquista After CRL

Lexicon stops development of its diabetes drug Zynquista that received an FDA complete response letter.

Clinical Investigation Protocol Deviations

FDA publishes a draft guidance on defining, identifying, and reporting protocol deviations in clinical investigations.