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

U.S health officials are updating the prescribing labels of long-acting ADHD medications to carry new warnings for children ...

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

The Breyanzi REMS program and the Abecma REMS program were established due to the risk of cytokine release syndrome and neurologic toxicities.

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

The FDA has published its proposed agenda for 2025 guidance, including new topics such as food colorings. Topics on the agenda are a priority for the Food and Drug Administration’s Human Foods Program ...

An FDA pilot program, known as the Commissioner’s Priority Voucher program, could drastically change the way pharmaceutical ...

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

Unicycive, which was seeking approval of oxylanthanum carbonate to treat hyperphosphatemia in patients with chronic kidney disease on dialysis, said the FDA issued a so-called complete response letter ...

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 says it will begin offering faster reviews to new medicines that align with Trump ...

The FDA announced a new national priority voucher plan that aims to cut drug review times, while Headspace launches direct-to ...