Austin, Texas, United States, August 25th, 2025, FinanceWire NRx Pharmaceuticals has filed a Citizen Petition with the FDA to ...

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 ...

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

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

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 denied approval for PTC Therapeutics' oral medication for a rare genetic disorder ...

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

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

Hey, good morning. Today, we see CBER suspend the license for a chikungunya vaccine, look at a push to recall a safety and ...

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