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 ...

These warning letters are the latest in a series of FDA efforts to crack down on companies selling birth-tissue-derived ...

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

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

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

said the U.S. Food and Drug Administration did not overstep its authority in approving MSN Pharmaceutical's generic of ...

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

While the regulator has not approved their use in type 1 diabetes, off-label prescribing for GLP-1 receptor agonists has ...