Rocket Pharmaceuticals Inc.
http://www.rocketpharma.com/
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Latest From Rocket Pharmaceuticals Inc.
EU Fast-Track Requests For Mozafancogene Autotemcel & Vorasidenib Signal Imminent Filings
The European Medicines Agency is this week deciding whether its reviews of planned marketing applications from Rocket Pharmaceuticals and Servier merit accelerated assessment status.
Breakthrough Bounceback Looks Unlikely At US FDA’s CDER, But CBER Is Riding Wave Of RMATs
Only two breakthrough-designated novel agents remain on the US FDA drugs center’s 2023 user fee calendar, while CBER stacks up on vaccines and gene therapies under both BTD and RMAT programs.
US FDA Struggling With Long-Term Follow-Up Requirements For Gene Therapies
OTP Director Nicole Verdun acknowledged the agency may need help to determine how to ensure 15 years of patient follow-up is completed despite physician retirements, company closures and other issues that could impact the post-market commitments for gene therapies.
Keeping Track: Regeneron’s Bispecific Bid, More Regenerative Medicine BLAs, And Vadadustat Returns
Highlights of recent submissions for approval from the Pink Sheet’s US FDA Performance Tracker
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Biotechnology
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- Inotek Pharmaceuticals
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