FDA Rejects Rocket’s Gene Therapy, Cites Need for Additional CMC Info

Submitted by admin on June 30, 2024 - 10:03pm

Source:

BioSpace

News Tags:

Rocket Pharmaceuticals

FDA

gene therapy

Kresladi.

Headline:

FDA Rejects Rocket’s Gene Therapy, Cites Need for Additional CMC Info

snippet:

Rocket Pharmaceuticals announced Friday that the FDA rejected its rare disease gene therapy Kresladi (marnetegragene autotemcel) in a Complete Response Letter requesting “limited additional” chemistry, manufacturing and controls information to complete the regulator’s review

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FDA Rejects Rocket’s Gene Therapy, Cites Need for Additional CMC Info

FDA Rejects Rocket’s Gene Therapy, Cites Need for Additional CMC Info