FDA Commissioner Marty Makary committed to Sen. Josh Hawley that the agency will conduct a safety review of the abortion pill mifepristone.

The FDA launched a generative artificial intelligence (AI) tool, dubbed Elsa, designed to help employees such as scientific reviewers and investigators work more efficiently, the agency announced ...

The FDA has launched the generative AI tool, Elsa, agency-wide to help its employees with everything from clinical reviews to investigations. Sure, we're living in a time of widespread ...

Following a successful pilot, the Food and Drug Administration unveiled its in-house large language model designed to help agency staff in drug clinical evaluations and reviews. FDA Artificial ...

READ: FDA promises to cut by half approval time for new products No hike for decades. The rate of fees and charges of the FDA has not been updated for more than 20 years since the implementation ...

The FDA and Stealth look set to relitigate the debate, with the biotech planning to file for approval once again. Stealth has laid off 30% of its staff to free up funds for the resubmission.

FDA warns of severe itching risk when stopping long-term use of allergy medications cetirizine and levocetirizine, affecting quality of life for some users.

Expert advisors for the Food and Drug Administration met Thursday to discuss which virus strain this year's updated COVID-19 vaccines should target. The advisors have been meeting around this time ...

The FDA’s recent activities regarding Covid-19 vaccines stray far from the well-established standards of vaccine regulatory processes.

The FDA has updated warning labels for Pfizer's Comirnaty and Moderna's Spikevax COVID-19 vaccines to note a rare risk of myocarditis and pericarditis, especially in males aged 16–25.

On Thursday, FDA Commissioner Marty Makary is slated to appear at 10:30 a.m. before the Senate Appropriations Subcommittee in charge of funding his agency.