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The U.S. FDA has approved privately held Italfarmaco Group's drug to treat Duchenne muscular dystrophy (DMD), an inherited muscle-wasting disorder, the health regulator said on Thursday. The oral ...
(Reuters) -The U.S. Food and Drug Administration allowed the expanded use of Sarepta Therapeutics' gene therapy for patients with Duchenne muscular dystrophy aged four and older on Thursday ...
Givinostat was approved for medical use in the United States in March 2024. [2] [5] Givinostat is the first nonsteroidal medication approved by the US Food and Drug Administration (FDA) to treat people with all genetic variants of Duchenne muscular dystrophy. [2] The FDA considers it to be a first-in-class medication. [6]
The U.S. Food and Drug Administration's (FDA) approval comes just months after the approval of Sarepta Therapeutics' Elevidys, the first gene therapy for DMD. Santhera's drug gets US FDA nod for ...
Delandistrogene moxeparvovec, sold under the brand name Elevidys, is a recombinant gene therapy used for the treatment of Duchenne muscular dystrophy. [3] It is designed to deliver into the body a gene that leads to production of Elevidys micro-dystrophin that contains selected domains of the dystrophin protein present in normal muscle cells. [3]
In October 2023, the FDA approved vamorolone (Agamree; Catalyst Pharmaceuticals) for the treatment of Duchenne muscular dystrophy. [ 11 ] [ 21 ] [ 22 ] In October 2023, the Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Agamree, intended ...
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