The FDA accepted the BLA submission for Tabelecleucel and granted Priority Review, with Pierre Fabre Pharmaceuticals Inc. preparing for approval.
2 reports, 2 independent
Updated Jul 24
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What happened
The FDA accepted the BLA submission for Tabelecleucel and granted Priority Review, with Pierre Fabre Pharmaceuticals Inc. preparing for approval.
Who's involved
What this event is mainly aboutHow it developed
Newest first. Tap a step to see who reported it.- Atara Biotherapeutics partnered with Pierre Fabre Pharmaceuticals, which is currently seeking regulatory approval for its products.Sub-event
FDA grants Priority Review for Tabelecleucel developed by Pierre Fabre Pharmaceuticals Inc.1 source
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The entities involved
- FDA
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Adriana Herrera
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Related events
- FDA and Pfizer are seeking regulatory approval for their products.
- FDA granted Priority Review for the BLA submission of the SkinTE product.
- The administration has signed an executive order and issued priority vouchers to accelerate the drug approval process through the FDA.
- Atrium and Bristol-Myers Squibb received IND clearance from the FDA and obtained a No Objection Letter for Canadian sites.
- The FDA suspended Pfizer's C&F Depot license.
Coverage
Newest first; wire copies grouped- PR NewswirePierre Fabre Pharmaceuticals Inc. Announces FDA Acceptance and Priority Review of the Biologics License Application (BLA) for Tabelecleucel for the Treatment of Epstein-Barr Virus Positive Post-Transp
- Business WireAtara Biotherapeutics Provides Regulatory and Business Updates on Tabelecleucel (Tab-cel®) Atara Biotherapeutics Resubmits Tabelecleucel (Tab-cel®) Biologics License Application for Treatment of Epst