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 ...

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

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 and Drug Administration has denied approval for PTC Therapeutics' oral medication for a rare genetic disorder ...

While the FDA is working on removing the pots from shelves, it has been unable to initiate a mass recall, the agency warned.

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, ...

Lead is toxic to people of any age or health status and higher exposure levels can lead to neurological changes ...