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

The U.S. Food and Drug Administration has approved GSK's autoinjector of Benlysta (belimumab) for subcutaneous injection in ...

The FDA said risks linked to CAR-T cell therapies can be effectively communicated through existing labeling, including boxed ...

Sabores Fit Bakery recalled a variety of its mousse desserts on June 20 because of the undeclared presence of allergens.

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

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

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

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

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 ...

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 a new variant that causes 'razor blade throat' spreads, the FDA updates vaccine warnings to include information on heart ...

U.S. health officials have expanded warnings about a rare heart side effect associated with the two leading COVID-19 vaccines ...