The FDA’s approval of the PMA is based on the ... Forward-looking statements This press release may contain predictions, estimates or other information that might be considered forward-looking ...

The approval marks the second for a generic in this class of medications indicated to improve glycemic control in patients ...

The US Food and Drug Administration has approved Zepbound (tirzepatide) as the first prescription medication for the treatment of obstructive sleep apnea (OSA).

The Food and Drug Administration is proposing a rule that cosmetic companies would have to take extra steps to ensure that ...

The FDA has granted breakthrough therapy designation Trodelvy for adults with extensive-stage small cell lung cancer who ...

The final rule of what qualifies as healthy on manufacturers' food packages was finalized by the U.S. Food & Drug ...

The FDA released a Declaratory Order on December 19th re-evaluating and essentially re-instituting its previous position on the tirzepatide shortage, declaring the shortage resolved. As a bit of ...

Gemtesa is approved for men with overactive bladder symptoms who are receiving pharmacologic treatment for benign prostatic hyperplasia.

a medical doctor and director of the FDA's Office of Cosmetics and Colors, said Thursday in a news release announcing the agency's action. The agency's proposed rule falls short of a ban on talc ...

A popular brand of eye drops is being recalled nationwide after a consumer reported a "foreign material" was found in a ...

After plugging billions into its manufacturing network to meet rampant demand for Mounjaro and Zepbound, Eli Lilly is looking ...