Nov. 6, 2024 – The FDA has updated the labels for all GLP-1 weight loss drugs with a warning about pulmonary aspiration ...

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.

FDA approves Autolus Therapeutics' Aucatzyl for adults with relapsed or refractory B-cell precursor acute lymphoblastic ...

The butter being recalled was sold exclusively in Texas, and according to a Food and Drug Administration report on the recall ...

The affected drugs are semaglutide (Ozempic, Rybelsus, Wegovy); liraglutide (Saxenda, Victoza); and the dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 tirzepatide (Mounjaro, Zepbound). ...

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

FDA's Human Foods Program released its 2025 Priority Deliverables today, which details the primary focuses for its first year under the reorganization. Highlights include a goal to issue guidance on ...

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

Trace One also reported that in recent years the number of food recalls issued by the FDA and the Food Safety and Inspection Service (FSIS) has increased. From 2020 to 2023, the total number of ...

Rhythm Technologies (Nasdaq:IRTC) announced that the FDA granted 510(k) clearance for Zio AT design modifications and ...

However, the company said it will delay a submission for its next-generation Zio cardiac monitoring system until remediation efforts are further along.

Jylamvo is an oral liquid formulation of methotrexate originally approved in 2022 for adults with acute lymphoblastic ...