For Sarepta, the hits keep coming, with several downgrades in the past week after it was forced to temporarily take its ...

The Food and Drug Administration won’t sign off on Sarepta Therapeutics Inc. bringing its controversial gene therapy back to ...

Kratom affects the same receptors in the brain as opioids, meaning that in high doses, it can produce similar euphoric and ...

Learn how ATTR-CM is treated with medications that slow down the condition's progression and other therapies that reduce symptoms and improve the quality of life.

BioPoly, an orthopedic startup based in Fort Wayne, is approaching the start of an FDA-approved clinical trial of a knee ...

The U.S. Food and Drug Administration has appointed George Francis Tidmarsh, M.D., Ph.D., as director of the Center for Drug Evaluation and Research (CDER).

The FDA is taking steps to ban current prescriptions.

Missouri's Republican attorney general filed a lawsuit on Wednesday accusing reproductive healthcare provider Planned ...

D r. James H. Bekker made it clear while standing at a podium in front of the U.S. Food and Drug Administration (FDA) in ...

U.S. Food and Drug Administration Commissioner Marty Makary said he is focused on overhauling long-held standards and ...

U.S. Food and Drug Administration employees told CNN that Elsa — the AI model that’s supposed to help speed up approvals of pharmaceuticals and medical devices — isn’t working great. Instead, it cites ...

There’s an active recall on over 100,000 ice cream bars sold in 23 states, according to the U.S. Food and Drug Administration (FDA). This is due to a potential Listeria monocytogenes contamination.