FDA Related News

Biologics

Breakthrough Designation for Pfizer RSV Vaccine Candidate

FDA grants a second breakthrough designation to Pfizers respiratory syncytial virus vaccine candidate, this time to prevent lower respiratory tract di...

Human Drugs

FDA Oks Change to Cabenuva Start-up Regimen

FDA approves a label update for Janssens Cabenuva to permit starting the injection treatment without an oral treatment lead-in.

Human Drugs

FDA Rejects Lilly BLA on Me-too PD-1 Inhibitor

FDA sends Eli Lilly and Innovent Biologics a complete response letter on its BLA for sintilimab injection, a me-too PD-1 inhibitor for treating certai...

Human Drugs

FDA Schedules Generic Drug Forum

FDA announces the dates and program for the Generic Drugs Forum 2022.

FDA Approves Novartis Pluvicto for Prostate Cancer

FDA approves Novartis Pluvicto for treating some prostate cancers and approves a radioactive diagnostic agent to identify candidates for Pluvicto ther...

Human Drugs

Amylyx ALS Drug May Cause FDA Problems: AP

An Associated Press report says an upcoming FDA advisory committee meeting to consider an Amylyx drug to treat ALS may raise issues similar to those p...

Human Drugs

PharmaTher to Work with FDA on Ketamine Phase 3 Study

PharmaTher says it will work with FDA toward a Phase 3 trial of its ketamine infusion to treat levodopa-induced dyskinesia in Parkinsons patients.

Human Drugs

Top Warning Letter Drug GMP Citations

CDER Office of Manufacturing Quality branch chief Maan Abduldayem outlines the Centers Top Recent Warning Letter Citations (FY 2019 to FY 2021).

Federal Register

Obstetrics, Reproductive Drugs Panel Renewed

Federal Register notice: FDA renews its Obstetrics, Reproductive and Urologic Drugs Advisory Committee for an additional two years.

Medical Devices

Artio Medical Embolization Device Cleared

FDA clears an Artio Medical 510(k) for its Solus Gold Embolization Device for peripheral vascular occlusion.