The FDA accepted the resubmitted Biologics License Application (BLA) from Atara Biotherapeutics, Inc. on September 4, 2025. Greg Ciongoli also assumed the role of Board Chair.
1 report, 1 independent
Updated Sep 4
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What happened
The FDA accepted the resubmitted Biologics License Application (BLA) from Atara Biotherapeutics, Inc. on September 4, 2025. Greg Ciongoli also assumed the role of Board Chair.
Who's involved
What this event is mainly aboutKeep exploring
The entities involved
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FDA
- Medicare eligibility rules affect AbbVie drug pricing, while the FDA regulates Creon's classification and approval for Medicare beneficiaries.
- Hemogenyx Pharmaceuticals Plc submitted an IND application for its HG-CT-1 therapy with the FDA and is building infrastructure for early commercialization in Europe.
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Atara Biotherapeutics, Inc.
clinical-stage biotechnology company
Nothing else this week.
Related events
- Vance Thompson Vision advocated for standard product approval during an FDA committee meeting chaired by Michael X. Repka.
- FDA communicated eligibility for accelerated approval for ProKidney Corp., which plans to present study results at ASN.
- FDA removed the clinical hold on Arbutus Biopharma Corporation's IND application, allowing potential clinical development.
Coverage
Newest first; wire copies grouped- Business WireAtara Biotherapeutics Announces Changes to Its Board of Directors THOUSAND OAKS, Calif, September 03, 2025--(BUSINESS WIRE)--Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunothera