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

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

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

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.

The U.S. Food and Drug Administration said on Friday it had eliminated risk evaluation and mitigation strategies (REMS), a ...

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

If the FDA charged food companies user fees it could strengthen its oversight of food safety, according to a recent study. The study, “Advancing the FDA’s ...

The FDA's breakthrough devices program helps the industry with faster review times, but the benefit to patients is unclear.