Amgen (AMGN) announced that the U.S. FDA has approved Uplizna as the first and only treatment for adults living with Immunoglobulin G4-related ...

The United States Food and Drug Administration (US FDA) has approved VYKAT™ XR, a significant milestone as the first approved treatment for hyperphagia in Prader-Willi syndrome (PWS).

The US Food and Drug Administration has delayed granting full approval of Novavax’s Covid-19 vaccine despite it being on ...

The U.S. Food and Drug Administration has approved expanded use of Amgen's drug, Uplizna, to help reduce the risk of flares ...

Revvity (RVTY) announced that the FDA has approved the Auto-Pure 2400 liquid handling platform with the T-SPOT.TB test. Initially launched ...

The Supreme Court on Wednesday threw out an appeals court ruling that found the FDA unlawfully handled approval requests made ...

The FDA is expected to decide on treatments for COPD, psoriasis, rare neuroendocrine tumors, and a next-generation COVID-19 vaccine.

The Supreme Court on Wednesday backed FDA regulatory actions to keep certain flavored e-cigarettes off the market.

Amgen (NASDAQ: NASDAQ:AMGN) announced that the U.S. Food and Drug Administration (FDA) has granted an expanded label approval ...

“As of Tuesday, April 1, we had responded to all of the FDA’s information requests and we believe that our [Biologics License Application] is ready for approval,” Novavax said in a ...

The Supreme Court backed the FDA's refusal to authorize the sale of kid-friendly flavored vapes, including the flavors ...