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

Benlysta is the first and only approved autoinjector biologic for both systemic lupus erythematosus and lupus nephritis ...

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 ...

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

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

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

The FDA published a report highlighting a "severe worsening of chronic inflammatory demyelinating polyradiculoneuropathy" as a potential signal of serious risk with Vyvgart Hytrulo (efgartigimod alfa ...

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 ...

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

The FDA plans to approve selected high-priority drug application submissions in 1 to 2 months rather than 10 to 12.