Rocket Pharmaceuticals Inc.
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Latest From Rocket Pharmaceuticals Inc.
Immuno-oncology will remain a major force at both FDA’s drugs and biologics centers, but watch for psychiatry and antibiotics to make some noise; rare pediatric diseases will remain prominent as the priority review voucher program heads into the sunset.
2023 saw a number of gene therapy companies go to the wall, but those that can combine clinical significance and commercial success can build sustainable businesses.
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.
- Gene Therapy, Cell Therapy
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