FDA Related News

Biologics

Vyvgart sBLA Seeks Expanded Use

FDA accepts for priority review an Argenx supplemental BLA seeking to expand the use of its myasthenia gravis drug Vyvgart.

Human Drugs

FDA Quietly Retires Autism Bogus Therapies Page

An Ars Technica post says FDA has dropped a Web page that listed some specific bogus autism treatments and therapies and warned of their potential hea...

Human Drugs

FDA Hits Altor Bio Over Promo Violations

FDA sends an untitled letter to Altor BioScience, alleging that promotional Web pages for bladder cancer drug Anktiva are false or misleading and viol...

Human Drugs

FDA, EMA Drug Development AI Principles

FDA and the European Medicines Agency publish their collaborative 10 guiding principles for using artificial intelligence in drug development and eval...

Medical Devices

Multiple Violations Seen in ASP Global Inspection

FDA warns Austell, GA-based Anatomy Supply Partners about multiple types of violations in its manufacturing of the Safe-T-Fill Micro Capillary Collect...

FDA General

Pazdur Warns About Political Interference, Upheaval At FDA

Former FDA Oncology Center for Excellence director Richard Pazdur warns that political interference and internal upheaval are eroding the agencys abil...

Human Drugs

FDA Extends Review for Filspari in Kidney Disease

FDA extends by three months its review of a Travere Therapeutics supplemental NDA for Filspari in focal segmental glomerulosclerosis.

Ways for FDA to Modernize Biotech Regulation

The National Security Commission on Emerging Biotechnology recommends 22 policy actions in five key areas to modernize FDA medical biotechnology regul...

Biologics

PharmaEssentia Besremi sBLA for Essential Thrombocythemia.

FDA accepts for review a PharmaEssentia supplemental BLA seeking to expand the label of its interferon therapy Besremi to include adults with essentia...

Human Drugs

Baxter Class 1 Recall of Sigma Infusion Pumps

FDA classifies as Class 1 a recall of certain Sigma Spectrum infusion pumps made by Baxter, warning that continued use of the affected devices could r...