The report for Congress specifies that lawmakers would need to help shape which products are allowed, and in what form.

FDA drug alerts in pulmonology, including drug approvals/warnings, vaccine approvals, medical device recalls/updates, and ...

KONFIDENT phase 3 trial results demonstrated significantly faster symptom relief with sebetralstat compared to placebo.

The Food and Drug Administration (FDA) recently issued warning letters to two third-party nonclinical testing laboratories.

The FDA has revised the EUA for Pemgarda (pemivibart), authorized for the preexposure prophylaxis of COVID-19.

The FDA has cleared the Epitomee capsule to support weight management in adults with a body mass index of 25 to 40kg/m2.

FDA Decision Expected by PDUFA Goal Date of October 25, 2024Potential to be First Oral Penem Approved in the U.S.DUBLIN and CHICAGO, Sept. 10, ...

Advertisement One week ago, the FDA approved the updated versions for Pfizer/BioNTech and Moderna, an mRAN. They are now available in some pharmacies. All these vaccines include a monovalent ...

1 strain of the virus. "Today's authorization provides an additional COVID-19 vaccine option," said Peter Marks, director of the FDA's Center for Biologics Evaluation and Research. Doses are on ...

Both Pfizer and Moderna’s shots target the KP.2 COVID-19 variant—JN.1 is the parent variant of KP.2. The FDA in June asked vaccine makers to create shots that target the coronavirus’ JN.

The Pfizer and Moderna recipes are tailored to a virus subtype called KP.2. The Novavax formula targets its parent strain, called JN.1. The FDA considers both closely enough related to currently ...

The FDA argues research shows that regardless of appearance, customers' ages are difficult for retailers to accurately discern from looks alone. Advertisement It further mandates that also ...