On a quest to bring its multiple myeloma antibody-drug conjugate Blenrep back to the U.S. | Members of the FDA's Oncologic Drugs Advisory Committee voiced concerns with ocular toxicity side ...

FDA Commissioner Marty Makary, M.D., has made his pick for the next director of the FDA’s Center for Drug Evaluation and Research (CDER) in veteran biotech executive George Tidmarsh, M.D., Ph.D.

The Food and Drug Administration (FDA) has authorized Juul Labs to keep its electronic cigarettes on the market, a major reversal after the agency completely banned the company’s products in … ...

FDA panel votes 10-1 against Otsuka's combination drug for PTSD Panel's decision echoes FDA reviewers' efficacy concerns Mixed trial results and adverse events raise doubts FDA decision on drug ...

The FDA’s approval of the natural food dye relates to the ongoing removal of petroleum-based dyes from major food brands, including Kraft Heinz, General Mills, and Nestle, just to name a few.

Insiders at the Food and Drug Administration are ringing alarm bells over the agency's use of an AI to fast-track drug approvals.

The FDA has rejected Replimune’s request for approval of RP1, adding the melanoma drug candidate to the list of assets to receive complete response letters from the new-look agency.

Believer Meats becomes the first non-U.S. company to receive FDA approval for cultivated meat, marking a milestone under the Trump administration.

The Trump administration has touted AI as a way to cut government staffing, but the FDA's new AI tool has been citing nonexistent studies.

The U.S. Food and Drug Administration named ex-biotech exec George Tidmarsh as its chief drug regulator. FDA Commissioner Marty Makary called Tidmarsh an "accomplished physician-scientist and leader." ...

FDA places clinical hold on Sarepta's LGMD gene therapy trials after three deaths and revokes platform tech designation due to safety concerns.