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

A separate section on patient-counseling information has been added in response to the requirement that all FDA-approved patient information be reprinted in or accompany drug product labeling.

Purpose: The revised prescription drug labeling developed by the Food and Drug Administration (FDA) is described. Summary: A new FDA final rule, "Requirements on Content and Format of Labeling for ...

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

Bristol-Myers Squibb has claimed FDA approval for a new, tumour-agnostic indication for Augtyro, the cancer drug it acquired as ... has now had its label extended to include all solid tumours ...

Abrysvo is now approved to prevent lower respiratory tract disease caused by RSV in high-risk adults over 18 years of age.

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

You may have heard about — or maybe even experienced — the short-term side effects of Ozempic® — such as nausea, vomiting, ...

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

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

The US FDA has approved Iterum Therapeutics' NDA for ORLYNVAH to treat uncomplicated urinary tract infections (uUTIs).