BMS’ Breyanzi Beats COVID-19 Constraints, Emerges As First RMAT Approval
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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Several new drugs are now on track for an EU marketing authorization after getting the EMA’s thumbs up this week.
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had earned a rare pediatric disease priority review voucher; agency says the notice was published in error and will be withdrawn.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.