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BMS’ Breyanzi Beats COVID-19 Constraints, Emerges As First RMAT Approval

Executive Summary

After missing user fee date due to inspection delay, US FDA clears the CAR-T therapy for treatment of adults with relapsed or refractory large B-cell lymphoma.

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Premature PRV: US FDA Mistakenly Announces Voucher Award For Enzyvant Ahead Of Approval

Congenital athymia treatment Rethymic (RVT-802) is still under FDA review, with an 8 October user fee goal date, but FDA announced the regenerative medicine product had earned a rare pediatric disease priority review voucher; agency says the notice was published in error and will be withdrawn.

Keeping Track: StrataGraft Continues US FDA’s Biologic Center Approvals Streak; Another CRL For Avenue’s Tramadol IV

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

Regenerative Medicine Designation More Useful 'Tool' Than CBER’s Marks Initially Anticipated

Biologics center director was skeptical that RMAT would offer much beyond US FDA's existing breakthrough therapy pathway, but he has since come to appreciate the flexibility offered by less stringent designation criteria and leeway in the types of potential confirmatory evidence.

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