Rocket Pharmaceuticals Inc.
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Latest From Rocket Pharmaceuticals Inc.
The European Medicines Agency is this week deciding whether its reviews of planned marketing applications from Rocket Pharmaceuticals and Servier merit accelerated assessment status.
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.
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.
Highlights of recent submissions for approval from the Pink Sheet’s US FDA Performance Tracker
- Gene Therapy, Cell Therapy
- Other Names / Subsidiaries
- Inotek Pharmaceuticals
- Renovacor Inc.
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