"The claim that the FDA is suspending routine food safety inspections is false. FDA is actively working to ensure continuity of operations during the reorganization period and remains committed to ...

Two common allergy medications could cause a severe reaction in some people who stop using it. The U.S. Food and Drug Administration (FDA) issued an alert related to cetirizine (Zyrtec) or ...

Orders to expand the warnings were posted Wednesday by the FDA, in letters dated April 17 to Pfizer and BioNTech about their Comirnaty vaccine and Moderna about its Spikevax vaccine. Both vaccines ...

FDA Commissioner Marty Makary and top U.S. vaccines regulator Vinay Prasad wrote in the New England Journal of Medicine that the benefit of repeated annual shots for healthy adults was uncertain ...

Johnson & Johnson has won the support of an FDA expert panel in its bid to make Darzalex the first treatment for an early form of multiple myeloma despite uncertainties raised by regulators.

The Food and Drug Administration’s recent activities regarding Covid-19 vaccines stray far from the well-established standards of vaccine regulatory processes. The first sign of trouble was the ...

The FDA is tightening its regulatory policy around COVID vaccines with a new framework that raises the bar for certain approvals. FDA Commissioner Marty Makary, M.D., and Center for Biologics ...

Novavax makes the nation’s only traditional protein-based coronavirus vaccine – and until now it had emergency authorization from FDA for use in anyone 12 and older. But late Friday ...

The Food and Drug Administration (FDA) says it’s only prioritizing covid vaccine approvals for adults older than 65 and others over the age of 6 months who have at least one “risk factor ...

LOOKING INTO VAX CRYSTAL BALL — The Covid-19 vaccine framework that FDA Commissioner Marty Makary teased last week is expected to drop today, two people familiar with the plan and granted ...

Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53. WASHINGTON — Lawmakers ...

The FDA said in a safety warning issued on May 16 that some patients who have taken oral allergy medicines daily for long periods of time — at least a few months but often several years — have ...