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The FDA accepted the BLA submission for Tabelecleucel and granted Priority Review, with Pierre Fabre Pharmaceuticals Inc. preparing for approval.

Steady: 0 in the last 7 days Updated oct 15

The latest in this situation

  1. FDA acceptance moves the drug closer to U.S. launch, following approvals from the EC and Switzerland.

How it started

3 reports, 3 independent, last reported Oct 14. The briefing below covers this first event.

AI-generated analysis. Brind wrote this summary from the reports listed below. It can be wrong. Each section says how much you can rely on it, and the sources are linked so you can check.

What happened

Well supportedReported by 3 independent outlets

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 about
FDAAdriana Herrera

How it developed

Newest first. Tap a step to see who reported it.
  1. Atara Biotherapeutics partnered with Pierre Fabre Pharmaceuticals, which is currently seeking regulatory approval for its products.Sub-event
  2. FDA grants Priority Review for Tabelecleucel developed by Pierre Fabre Pharmaceuticals Inc.1 source

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The entities involved

Related events

Coverage

Newest first; wire copies grouped
  • prnewswire.com
  • 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