The US Food and Drug Administration approved 50 new molecular entities in 2024 —just five fewer than it did in 2023. Last ...

Back in October, Pfizer won the FDA’s favor on its own TFPI drug Hympavzi, which is specifically approved in hemophilia A or B patients who have not developed antibodies to previous inhibitor ...

Among the FDA’s pending decisions for this quarter are Vertex’s non-opioid pain drug and Sanofi’s RNA interference therapy ...

Sangamo Therapeutics, Inc. (NASDAQ:SGMO) regained the development and commercialization rights to giroctocogene fitelparvovec ...

Dec 20 (Reuters) - The U.S. Food and Drug Administration ... type of hemophilia develop those antibodies, according to the FDA. In October, the U.S. health regulator approved Pfizer's (PFE.N ...

By the end of March, the regulator could clear a highly anticipated pain drug from Vertex and a heart drug that’s critical to ...

The FDA last year also approved several drugs designed to treat familiar ... from a new class that doesn't directly block ...

Newer hemophilia drugs are entering the market, giving patients even more choices. Pfizer has one of them with Hympavzi, a once-weekly injectable drug approved by the FDA in October for both ...

Also Read: FDA Approves Pfizer’s Second Hemophilia Drug With Six Months In July 2024, Pfizer announced topline results from the Phase 3 AFFINE trial of giroctocogene fitelparvovec, which ...

Phase 3 study could pave the way for a Pfizer product to become the second US Food and Drug Administration (FDA)-approved gene therapy for hemophilia A. In an efficacy population of 50 patients ...

Pfizer’s anti-TFPI antibody marstacimab has been approved by the FDA to treat haemophilia ... in patients aged 12 and older and is the first drug in the anti-TFPI class to be approved in ...