FDA Related News

Human Drugs

GSK Pulls Blenrep Accelerated Approval at FDAs Request

At FDAs request, GSK is withdrawing the accelerated approval for Blenrep (belantamab mafodotin-blmf) due to the therapys poor showing in progression-f...

Human Drugs

New Hemophilia B Gene Therapy Approved

FDA approves Behrings Hemgenix to treat some adults with Hemophilia B.

Multiple Violations at Invitrx Therapeutics

FDA warns Lake Forest, CA-based Invitrx Therapeutics about illegally marketing cellular and acellular products and CGMP and CGTP violations in the man...

Federal Register

Guide on Compounding Beta-Lactam Products

Federal Register notice: FDA makes available a final guidance entitled Compounding Certain Beta-Lactam Products in Shortage Under Section 503A of the ...

Medical Devices

Latest Philips Respironics MDRs

FDA reports on the latest three months of medical device reports on some Philips Respironics ventilators, BiPAP, and CPAP machines.

Human Drugs

Webinar on Rx Drug Labeling Resources

FDA announces a 1/26/2023 Webinar entitled FDAs Labeling Resources for Human Prescription Drugs that will discuss new resources available for the phar...

Medical Devices

FDA Updates Web Page on Medtronic HeartWare Recalls

FDA updates a Web page it maintains on Medtronic recalls involving its HeartWare Ventricular Assist Device system that is intended to enhance user acc...

Federal Register

ORA Reorganization Notice Corrected

Federal Register notice: FDA corrects a 9/28 notice entitled Statement of Organization, Functions, and Delegations of Authority that discussed a reorg...

Medical Devices

Zimmer Biomet New Persoa Tibis Cleared

FDA clears a Zimmer Biomet 510(k) for the Persona OsseoTi Keel Tibia for cementless knee replacement.

Human Drugs

FDA OKs Jazz sBLA for Mon./Wed./Fri. Rylaze Dosing

FDA has approved a Jazz Pharmaceuticals supplemental BLA to add a Monday/Wednesday/Friday intramuscular dosing schedule for Rylaze (asparaginase erwin...