Following an inspection that ran from July 29 to Aug. 2, the FDA handed Global Calcium a six-observation Form 483. The heavily redacted document was posted online by the U.S. regulator on Wednesday.

The approval marks first indication for Keytruda in MPM in the US, MPM is a rare, aggressive cancer around the lining of the lungs and chest Wednesday, the FDA approved Merck & Co Inc’s MRK ...

Wednesday, the FDA approved Merck & Co Inc’s (NYSE:MRK) Keytruda (pembrolizumab) in combination with pemetrexed and platinum chemotherapy for the first-line treatment of adult patients with ...

Some 30 million adults report some form of hearing loss, according to the FDA, which said the impairment could negatively affect one's communication, relationships, performance and well-being.

The FDA’s Center for Drug Evaluation and Research (CDER) is consolidating its artificial-intelligence-related activities under a single AI Council, in part in response to efforts from the Biden ...

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 ...

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 ...

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 ...

After the U.S. Food and Drug Administration (FDA) approved the emergency use of the 2024-2025 COVID-19 vaccines many questions are beginning to circulate. In the FDA's press release on Aug. 22 ...

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.