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

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

Boston: TOBY, Inc., a biotech startup advancing non-invasive cancer detection through urine-based volatilomics and Artificial ...

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

Hemispherian AS, a pioneering biotech company developing next-generation therapeutics for aggressive cancers, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug ...

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 ...

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

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

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 ...

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.

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