FDA Related News

FDA Approves Rozlytrek Companion Diagnostic

FDA approves a Foundation Medicine blood-based companion diagnostic for Genentechs cancer drug Rozlytrek.

Biologics

Group Urges Postponement of Alzheimers Drug Decision

Public Citizen calls on FDA to postpone a 1/6-expected accelerated approval decision on a Biogen/Eisai Alzheimers drug until after an advisory committ...

Human Drugs

Build Flexibility into Pubertal Development Guidance: BIO

The Biotechnology Innovation Organization suggests modifications to an FDA draft guidance on measuring growth and evaluating pubertal development in p...

Human Drugs

AstraZeneca BLA for RSV Prevention in Infants

FDA accepts for review an AstraZeneca BLA for nirsevimab for preventing respiratory syncytial virus lower respiratory tract disease in newborns and in...

Federal Register

3 Federal Register Notices on New Device Classifications

FDA publishes three Federal Register notices on device classifications related to de novo requests.

Human Drugs

FDA Delays PDUFA Action Date for Phathoms Vonoprazan

FDA says it is delaying the PDUFA action date for Phathoms vonoprazan to treat erosive esophagitis while the company submits additional stability data...

Human Drugs

New Alzheimers Drug OK This Week Wont Do Much for Patients: Article

As FDA prepares a review decision this week on an Eisai and Biogen BLA for Alzheimers drug lecanemab, an article in The Free Press reminds readers abo...

Human Drugs

REMS Document Format, Content Guidance

FDA publishes a guidance on the format and content for the REMS document portion of a REMS submission.

Medical Devices

Arrow MAC Venous Access Kit Recall is Class 1

FDA says the Teleflex recall of some Arrow MAC venous catheter kits is Class 1.

Medical Devices

Arrow Intra-Aortic Balloon Pump Recall is Class 1

FDA says the Arrow International recall of some intra-aortic balloon pumps for battery depletion issues is Class 1.