- Sarepta Therapeutics Announces Expanded US FDA Approval of ...🔍
- FDA Expands Approval of Gene Therapy for Patients with Duchenne ...🔍
- US FDA approves expanded use of Sarepta's Duchenne gene therapy🔍
- Sarepta Therapeutics Announces U.S. FDA Acceptance of an ...🔍
- Sarepta Wins Full Approval and Label Expansion for DMD Gene ...🔍
- FDA broadens label for Sarepta's Duchenne gene therapy Elevidys🔍
- FDA expands approval of first gene therapy for rare form of muscular ...🔍
- As FDA Expands Approval of a New Gene Therapy to Treat ...🔍
US FDA approves expanded use of Sarepta's Duchenne gene therapy
Sarepta Therapeutics Announces Expanded US FDA Approval of ...
FDA grants traditional approval to ELEVIDYS for ambulatory Duchenne patients – FDA grants accelerated approval to ELEVIDYS for ...
FDA Expands Approval of Gene Therapy for Patients with Duchenne ...
Today, the U.S. Food and Drug Administration expanded the approval of Elevidys (delandistrogene moxeparvovec-rokl), a gene therapy for the ...
US FDA approves expanded use of Sarepta's Duchenne gene therapy
The U.S. Food and Drug Administration allowed the expanded use of Sarepta Therapeutics' gene therapy for patients with Duchenne muscular ...
Sarepta Therapeutics Announces U.S. FDA Acceptance of an ...
(NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced the U.S. Food and Drug Administration (FDA) has accepted and filed ...
Sarepta Wins Full Approval and Label Expansion for DMD Gene ...
On the heels of a Phase III flop for Pfizer's Duchenne muscular dystrophy gene therapy candidate, the FDA has green lighted the expanded use ...
Sarepta Therapeutics Announces Expanded US FDA Approval of ...
First approved by the FDA under the accelerated approval pathway for boys ages 4-5 with Duchenne in June 2023, ELEVIDYS is the first approved gene therapy for ...
FDA broadens label for Sarepta's Duchenne gene therapy Elevidys
The FDA has expanded the label for Sarepta's Duchenne muscular dystrophy gene therapy Elevidys to all patients age 4 and older.
FDA expands approval of first gene therapy for rare form of muscular ...
The US Food and Drug Administration has given the green light for the first gene therapy that treats a rare form of muscular dystrophy to be ...
As FDA Expands Approval of a New Gene Therapy to Treat ...
The new approval opens the gene therapy to a wider range of children with Duchenne muscular dystrophy, a rare genetic disorder that worsens ...
Sarepta Duchenne gene therapy wins broader use from FDA
The FDA last June approved Elevidys only for certain boys between 4 and 5 years of age, a group Sarepta estimates to total about 400 in the U.S. ...
For the treatment of DMD in patients who are non-ambulatory and have a confirmed mutation in the DMD gene (1, 12.2) The DMD indication in non- ...
FDA approves Sarepta's Duchenne gene therapy for nearly all patients
The Food and Drug Administration on Thursday approved Elevidys, Sarepta Therapeutics' gene therapy for Duchenne muscular dystrophy, ...
Sarepta stock surges 30% as investors cheer expanded use of gene ...
The U.S. FDA allowed the expanded use of Sarepta's gene therapy for all patients with Duchenne muscular dystrophy aged four and above on ...
FDA Grants 2 Approvals to Delandistrogene Moxeparvovec for DMD
The FDA has expanded its approval of delandistrogene moxeparvovec-rokl (Elevidys; Sarepta Therapeutics) to treat Duchenne muscular dystrophy ( ...
FDA Approves Sarepta's DMD Gene Therapy Elevidys for Expanded ...
1.Sarepta Therapeutics Announces Expanded US FDA Approval of ELEVIDYS to Duchenne Muscular Dystrophy Patients Ages 4 and Above. News release. · 2 ...
About Us - Muscular Dystrophy Association
Muscular Dystrophy Association Announces Expanded US FDA Approval of ELEVIDYS Gene Therapy for Duchenne Muscular Dystrophy Patients Ages 4 and ...
FDA expand approval for Sarepta Therapeutic gene therapy Elevidys
US Food and Drug Adminisatration has expanded the approval of Elevidys for the treatment for ambulatory and non-ambulatory people with ...
FDA Expands Approval of Sarepta Therapeutics' Elevidys for the ...
Elevidys should not be taken by patients with deletions in exon 8 and/or exon 9 of the DMD gene. 1. “Representing many years of dedicated ...
Sarepta Therapeutics Announces Expanded US FDA Approval of ...
Sarepta Therapeutics Announces Expanded US FDA Approval of Elevidys to Duchenne Muscular Dystrophy Patients Ages 4 and Above ... CAMBRIDGE, Mass.
FDA Approves Sarepta Gene Therapy, But Only After Top FDA ...
FDA reviewers concluded the data for Sarepta Therapeutics' Elevidys were insufficient to show efficacy in the rare muscle disorder Duchenne ...