FDA Related News

Biologics

Moderna Flu/Covid Vaccine Beats Comparators: Study

A Moderna Phase 3 study says its combination mRNA flu and Covid-19 vaccine achieved a greater immune response than comparator standard of care vaccine...

Human Drugs

Omeros BLA Resubmission for Narsoplimab

FDA accepts for review an Omeros BLA resubmission for narsoplimab for treating hematopoietic stem cell transplant-associated thrombotic microangiopath...

FDA General

Bill Would Create FDA Inspector General

Sen. Eric Schmitt introduces legislation to create an inspector general for FDA and two other public health agencies.

Human Drugs

Oncologic Panel to Review 4 Cancer Submissions

FDA announces a 5/20-21 Oncologic Drugs Advisory Committee meeting to review and vote on four cancer drug submissions.

Biologics

FDA Panel to Mull Covid Vaccine Strain Selection

FDA announces a 5/22 Vaccines and Related Biological Products Advisory Committee meeting to discuss and make recommendations on the selection of the 2...

Michael Rogers Resigns from FDA

CBS News reports that FDA associate commissioner for inspections and investigations Michael Rogers is retiring, frustrated over changes being made by ...

FDA General

FDA Picks Booz Allens Walsh as AI Chief

FDA taps former Booz Allen Hamilton chief technologist Jeremy Walsh to lead its artificial intelligence (AI) and information technology efforts in a n...

FDA General

Teva/Alvotechs Interchangeable Stelara Biosimilar OKd

FDA approves Teva Pharmaceuticals and Alvotechs Selarsdi injection as an interchangeable biosimilar to Janssens reference biologic Stelara (ustekinuma...

More Unannounced Foreign Inspections Coming

FDA says it is expanding the use of unannounced inspections of foreign medical product and food manufacturing facilities.

Human Drugs

FDA Ordered to Speed U.S. Drug Manufacturing

President Trump signs an Executive Order requiring FDA to take steps to increase domestic drug manufacturing.