The U.S. Food and Drug Administration said on Monday that it is revising the labeling of all extended-release stimulants to ...

San Francisco-based Wildtype, a startup that is pioneering cell-grown salmon, cleared a U.S. Food and Drug Administration ...

Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced alignment with the United States Food and Drug Administration (FDA) on items ...

The elimination of 3,500 full-time employees at the FDA risks undermining the very innovation and domestic capacity the ...

The U.S. Food and Drug Administration said on Monday it is revising the labeling of all extended-release stimulants used to ...

Previously, due to the risk of cytokine release syndrome and neurological toxicities, many CAR T-cell therapies included a REMS requirement.

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...

The Food and Drug Administration has approved Harliku (nitisinone) for the reduction of urine homogentisic acid in adult patients with alkaptonuria.

Qualifying manufacturers will be able to submit some data while clinical trials are ongoing. Marty Makary is the commissioner ...

The Food and Drug Administration says it will begin offering faster reviews to new medicines that align with Trump ...

Curay, the top FDA drug regulator, acknowledged that much is still in flux at the agency and introduced a new deputy.