Laboratories face a series of upcoming deadlines to comply with stricter FDA oversight of in-house tests. Here are five ...

The FDA has approved updated labeling for Flublok (influenza vaccine) to include new safety data involving pregnant individuals.

Vazalore is currently the only FDA-approved human aspirin that may be used in food-producing animals under certain conditions ...

Dietary supplements aren't FDA-approved like drugs. The director of the Office of Dietary Supplements offered advice ...

Avadel Pharmaceuticals plc AVDL announced that the FDA has approved its supplemental new drug application (sNDA) seeking ...

Sanofi (SNYNF, SNY) said that the U.S. Food and Drug Administration has updated the label for FLUBLOK (Influenza Vaccine) to include ...

As a host of generics circle the gates, Novartis has lost another bid to waylay MSN Pharmaceuticals’ copycat of the Swiss ...

Despite recent concerns from the FDA about potential off-label use and antimicrobial resistance, Dublin-based Iterum ...

Iterum Therapeutics (ITRM) plc announced that the U.S. Food and Drug Administration has approved Iterum’s new drug application for ...

Rhythm Technologies (Nasdaq:IRTC) announced today that it received FDA 510(k) clearance related to design changes made to its ...

The U.S. Food and Drug Administration has approved AbbVie's Vyalev (foscarbidopa and foslevodopa) for adults living with ...

Off-label SGLT2 inhibitors increase the risk of euglycemic diabetic ketoacidosis. GLP-1RAs may lead to rapid weight loss in ...