News

The FDA granted Sarepta’s rAAVrh74 Viral Vector a Platform Technology Designation
The FDA has designated the viral vector rAAVrh74, which Sarepta Therapeutics, Inc. (NASDAQ:SRPT) uses in its gene therapy ...
Precision Medicine Online5h
FDA Grants Platform Technology Designation to Viral Vector Used in Sarepta's LGMD Gene Therapy
Sarepta is the first company to publicly disclose that it's received the designation, for which the FDA had issued a draft guidance last year.
BioSpace1d
Sarepta Wins FDA’s Platform Technology Designation, Marking ‘Critical Shift’ in Gene Therapy Development
The Platform Technology Designation, which predates the current FDA leadership, is designed to streamline the drug ...
Clinical Advisor6h
FDA Approves Moderna’s Next-Generation COVID-19 Vaccine mNexspike
The new vaccine is indicated for individuals who have been previously vaccinated with any COVID-19 vaccine and are 65 years or older, or 12 to 64 years of age with at least 1 underlying condition that ...
Zacks Investment Research on MSN1d
FDA Grants Platform Technology Tag to Sarepta's Gene Therapy Vector
Sarepta Therapeutics SRPT announced that the FDA has granted platform-technology designation to its viral vector rAAVrh74, ...
BioPharma Dive1d
FDA to use new review tool on Sarepta’s gene therapy work
The company is one of the first to receive a “platform technology designation,” which could speed the review of certain gene ...
Morningstar2d
U.S. FDA Grants Platform Technology Designation to the Viral Vector Used in SRP-9003, Sarepta’s Investigational Gene Therapy for the Treatment of Limb Girdle Muscular ...
U.S. FDA Grants Platform Technology Designation to the Viral Vector Used in SRP-9003 ... for consideration if it is incorporated in an approved drug and preliminary evidence demonstrates that ...
The American Journal of Managed Care7d
Hurdles Remain Despite Progress in Gene Therapy for DMD
Advancements in gene therapy for Duchenne muscular dystrophy (DMD) have improved the outlook for some patients, but further ...
pharmaphorum4d
FDA approves Adstiladrin as first gene therapy for NMIBC
The US Food and Drug Administration (FDA) has approved Swiss drugmaker Ferring ... (cannot multiply in human cells) adenoviral vector-based gene therapy. Its safety and efficacy was evaluated ...