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 ...

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

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

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

There have been 4 new reports of serious adverse events related to Ixchiq based on updated Vaccine Adverse Event Reporting System data.

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

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

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

Quest Diagnostics (NYSE: DGX), a leading provider of diagnostic information services, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for ...

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

The FDA has extended the review for the BLA for clemidsogene lanparvovec for the treatment of MPSII, also known as Hunter Syndrome.