FDA should judge drugs on what they do in real life, not just in companies’ clinical trials by Aaron Kheriaty, opinion contributor - 07/08/25 7:00 AM ET AP Photo/Elise Amendola, file ...

WASHINGTON (AP) — The Food and Drug Administration has issued a long-awaited approval of Novavax’s COVID-19 vaccine but with unusual restrictions. Novavax makes the nation’s only traditional ...

FDA's Makary commits to reviewing abortion pill mifepristone safety data while listening to concerns, stating he has no plans for policy changes.

According to the federal agency, the letters are responses to applications submitted to the FDA for approval of drugs or biological products between 2020 and 2024. However, certain CRLs shared ...

The FDA gave permission for the sale of a brand of e-cigarettes — saying the product can help adult quit smoking. At the same time, it rejected many flavored products which are popular with teens.

FDA panel on the use of antidepressants during pregnancy is alarming experts The U.S. Food and Drug Administration campus in Silver Spring, Md. (Andrew Harnik / Associated Press) ...

The FDA has upgraded its warning about potentially deadly blueberries, indicating a ‘reasonable probability’ of serious health harms or death. The federal agency’s update followed a recall ...

FDA Commissioner Dr. Marty Makary joins Morning Joe to address the agency’s controversial decision to keep Juul e-cigarettes on the market, ongoing reviews of mifepristone, and the latest ...

The FDA is revoking or proposing to revoke 52 food standards (such as canned fruits, dairy, and baked goods), citing that they’re outdated and not aligned with current consumer needs or food ...

After 100 days of leading the Food and Drug Administration (FDA), I have seen first-hand how the agency needs to modernize and adapt to the health challenges facing our country. That's why we've ...

The FDA identified over 200 global cases of pruritus after stopping use of the medicines between April 2017 and July 2023, the agency shared. While an estimated 60 million-plus packages of the ...

On October 29, 1959, the pharmaceutical company G.D. Searle filed an application with the U.S. Food and Drug Administration (FDA) to license their drug Enovid for use as an oral contraceptive.