FDA Related News

Human Drugs

Jazz Pharma Hypersomnia Drug Approved

FDA approves a Jazz Pharmaceuticals NDA for Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for treating idiopathic hypersomn...

Biologics

Clinical Hold on Bluebird Bio Gene Therapy

FDA places a clinical hold on Bluebird Bios Lenti-D (elivaldogene autotemcel) after the company reported a suspected unexpected serious adverse reacti...

Federal Register

Comments Sought on Pre-Hatch-Waxman ANDAs

Federal Register notice: FDA solicits comments on several issues related to FDAs post-approval regulation of certain drug products approved in abbrevi...

Medical Devices

Baxter Recalls Infusion Pump Dosing Software

Baxter Healthcare recalls its Dose IQ Safety Software used with the Spectrum IQ Infusion System due to a software defect.

Human Drugs

Breakthrough Granted to Nasopharyngeal Carcinoma Drug

FDA grants a breakthrough therapy designation to Shanghai Junshi Biosciences and Coherus BioSciences for toripalimab in combination with chemotherapy ...

FDA or Courts Should Rethink Off-Label Rules: Cato

The Cato Institute says if FDA wont resolve its conflicting stance over off-label use and promotion, the courts should do so.

Human Drugs

Vifor Asks FDA to Reverse Some Venofer Actions

Vifor asks FDA to take specific steps to stay actions the agency took in a 2020 citizen petition response purporting to change the established names a...

Federal Register

FDA Seeks Consumer Reps for Advisory Panels

Federal Register notice: FDA seeks consumer organizations interested in participating in the selection of voting and nonvoting consumer representative...

Human Drugs

Appeals Court Says Teva Carvedilol Sale Induced Patent Infringement

The Federal Circuit Court of Appeals says promotional materials developed by Teva were enough to induce infringement of a GSK carvedilol patent despit...

Medical Devices

Captains Cloth Selling Unapproved KN95 Masks: FDA

FDA warns Captains Cloth it is marketing unapproved, adulterated, and misbranded KN95 face masks.