FDA approves Pfizer’s Hympavzi for routine prophylaxis in hemophilia A and B patients, offering a once-weekly dosing via auto-injector pen. Phase 3 trial showed Hympavzi reduced bleeding rates ...

The FDA has approved Imuldosa (ustekinumab-srlf), a biosimilar referencing Stelara (ustekinumab), for the treatment of autoimmune diseases such as plaque psoriasis, psoriatic arthritis ...

The FDA has approved a new flu vaccine nasal spray for at-home use. While this self-administered version won't be available for this year's flu season, interest in nasal spray products is growing.

Imuldosa (ustekinumab-srlf) is the fifth ustekinumab biosimilar referencing Stelara to receive regulatory approval in the US. The FDA has approved Imuldosa (ustekinumab-srlf), a biosimilar referencing ...

The US Food and Drug Administration (FDA) has approved Hympavzi (marstacimab, Pfizer) as routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients 12 years or older ...

The Food and Drug Administration (FDA) announced Friday it has approved the first flu vaccine that can be self-administered, with this version being a nasal spray as opposed to an injection.

The FDA has approved Amgen and Allergan’s biosimilar of Roche’s Herceptin, just in time for the breast cancer blockbuster’s patent expiry. Herceptin’s main US patent expires this month ...

The FDA is clearing the way for an at-home flu vaccines. A self-administered version of pharmaceutical giant AstraZeneca’s FluMist was approved Friday by regulators for household administration ...

Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a statement. The FluMist vaccine, manufactured by AstraZeneca, had previously been approved back in 2003 to ...

AQNEURSA™ (ak-nur-sah) is the only FDA-approved stand-alone therapy for the treatment of Niemann-Pick disease type C (NPC) Approval follows positive Phase III data demonstrating significant ...

“This drug takes the first new approach to schizophrenia treatment in decades,” Tiffany Farchione, director of FDA’s division of psychiatry, said in a statement. “This approval offers a ...

No new treatments for schizophrenia have been approved in nearly three decades, but that changed on Sept. 26, when the U.S. Food and Drug Administration (FDA) approved Cobenfy for the psychiatric ...