The Platform Technology Designation, which predates the current FDA leadership, is designed to streamline the drug ...

The company is one of the first to receive a “platform technology designation,” which could speed the review of certain gene ...

The FDA has designated the viral vector rAAVrh74, which Sarepta Therapeutics, Inc. (NASDAQ:SRPT) uses in its gene therapy ...

Sarepta Therapeutics SRPT announced that the FDA has granted platform-technology designation to its viral vector rAAVrh74, ...

US rare disease meds developer Sarepta Therapeutics (Nasdaq: SRPT) revealed that its rAAVrh74 viral vector used in the ...

Sarepta is the first company to publicly disclose that it's received the designation, for which the FDA had issued a draft guidance last year.

“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 ...

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, ...

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 ...

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 ...