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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 ...
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FDA Grants Platform Technology Tag to Sarepta's Gene Therapy Vector
With FDA platform technology designation for its viral vector, SRPT can fast-track other therapies using the same ...
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 ...
BioPharma Dive3d
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 ...
The Pharma Letter2d
FDA grants Platform designation for Sarepta’s SRP-9003
US rare disease meds developer Sarepta Therapeutics (Nasdaq: SRPT) revealed that its rAAVrh74 viral vector used in the ...
Morningstar4d
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, Sarepta’s Investigational Gene Therapy for the Treatment of Limb Girdle Muscular Dystrophy Type 2E/R4 ...
Seeking Alpha3d
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 ...
“This is one of the first programs to receive platform technology designation and an important recognition by FDA of the reproducibility and adaptability of this technology across multiple ...
Pharmabiz1d
Sarepta Therapeutics’ gene therapy to treat limb girdle muscular dystrophy type 2E/R4 gets US FDA platform technology designation
Sarepta Therapeutics’ gene therapy to treat limb girdle muscular dystrophy type 2E/R4 gets US FDA platform technology designation: Cambridge, Massachusetts Friday, June 6, 2025, ...
Insider Monkey2d
The FDA granted Sarepta’s rAAVrh74 Viral Vector a Platform Technology Designation
Future approvals of treatments utilizing the same delivery technology might be accelerated by this designation. Phase III EMERGENE studies for SRP-9003, sometimes referred to as bidridistrogene ...
Investing3d
Sarepta gene therapy vector gets FDA platform designation
The FDA’s platform technology designation aims to expedite drug development, manufacturing, and review processes by allowing sponsors to use prior data from the platform to support new drug ...