When it comes to the use of PD-1 inhibitors in stomach cancer, the FDA has put its money where its mouth is. | After questioning the benefits of checkpoint inhibitors in stomach cancer cases ...

Attorneys general of New York, California, New Jersey and Massachusetts are asking the Food and Drug Administration (FDA) to expand access to the abortion pill and remove some “unnecessary ...

Four Democrat-led states ask FDA to remove abortion pill restrictions The attorneys general of New York, California, Massachusetts and New Jersey asked the FDA to lift some requirements on ...

AI-driven Clairity Breast platform, now FDA-approved, predicts five-year breast cancer risk from mammograms, enhancing early detection and prevention.

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

The FDA may be facing a 4% cut to its overall budget courtesy of the Trump administration, but that hasn’t stopped the agency from unveiling a new generative AI tool a month ahead of schedule ...

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

WASHINGTON — Food and Drug Administration Commissioner Marty Makary said the agency is planning to unveil new guidance for vaccine makers, focused primarily on Covid-19 shots, in the coming weeks.

In the wake of mass restructuring efforts across the Department of Health and Human Services, the FDA has missed another approval decision target date.

High-ranking OpenAI employees have met with the FDA multiple times in recent weeks to discuss AI and a project called cderGPT.

The FDA has named Vinay Prasad, an oncologist who has previously criticized COVID-19 restrictions, as the director of its Center for Biologics Evaluation and Research.

FDA to increase surprise inspections at foreign facilities as U.S. companies pour billions into domestic drug and device manufacturing.