With the FDA’s go-ahead, Coya plans to launch a multicenter phase 2 trial of COYA 302 in patients with ALS, CEO Arun ...

The recalls have been classified as Class II, where the probability of serious adverse health consequences is remote.

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its ...

Drugmaker Novo Nordisk received accelerated approval for the drug’s use in people with moderate to advanced liver scarring, ...

The U.S. FDA has advised the public to not eat, sell, or serve certain imported frozen shrimp from an Indonesian firm as it ...

The U.S. Food and Drug Administration has cleared the Signos Glucose Monitoring System, an over-the-counter glucose ...

The Food and Drug Administration approved Papzimeos (zopapogene imadenovec-drba) for the treatment of adults with recurrent ...

Wegovy is now approved by FDA for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis.

The FDA approved Monjuvi with Revlimid and Rituxan for follicular lymphoma, the same combination that brought survivor Troy ...

On Tuesday, the Food and Drug Administration (FDA) warned consumers about potential contamination of a well-known brand of ...

A series of panels convened by the Food and Drug Administration is raising concerns that the agency is skirting federal rules ...

The U.S. Food & Drug Administration (FDA) has announced a recall on a limited lot of Blue Bell Ice Cream due to the presence ...