JD Supra

FDA Rolls Out Innovative New Designation Programs in Response to Congressional Mandates

Many life sciences stakeholders are familiar with “traditional” designation programs operated by the Food and Drug Administration (FDA) in exercising its medical product authorities, such as the ...
Nasdaq

Krystal Biotech Receives FDA Platform Technology Designation for HSV-1 Viral Vector Used in KB801 for the Treatment of Neurotrophic Keratitis

PITTSBURGH, Oct. 14, 2025 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) announced today that the United States Food and Drug Administration (FDA) granted platform technology ...
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Sarepta Viral Vector Gets FDA Platform Technology Designation

Sarepta Therapeutics Inc. (NASDAQ:SRPT) is one of the best mid cap growth stocks to invest in now. Earlier on June 4, Sarepta Therapeutics announced that the US FDA has granted Platform Technology ...
JD Supra

Recent FDA Guidance Addressing Platform Technologies

On May 29, 2024, the U.S. Food and Drug Administration (“FDA”) released draft guidance titled Platform Technology Designation Program for Drug Development. The draft guidance describes the process for ...
Seeking Alpha

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 ...

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Sarepta Therapeutics, Inc. (SRPT), the leader in precision genetic medicine for rare diseases, today announced that the rAAVrh74 viral vector used in the ...