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Atara Biotherapeutics (ATRA) FDA Events

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FDA Events for Atara Biotherapeutics (ATRA)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Atara Biotherapeutics (ATRA). Over the past two years, Atara Biotherapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Tabelecleucel. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Tabelecleucel (tab-cel) - FDA Regulatory Timeline and Events

Tabelecleucel (tab-cel) is a drug developed by Atara Biotherapeutics for the following indication: Post-Transplant Lymphoproliferative Disease (PTLD). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Atara Biotherapeutics FDA Events - Frequently Asked Questions

As of now, Atara Biotherapeutics (ATRA) has not received any FDA approvals for its therapy in the last two years.

In the past two years, Atara Biotherapeutics (ATRA) has reported FDA regulatory activity for Tabelecleucel (tab-cel).

The most recent FDA-related event for Atara Biotherapeutics occurred on January 21, 2025, involving Tabelecleucel (tab-cel). The update was categorized as "Clinical Hold," with the company reporting: "Atara Biotherapeutics, Inc announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on Atara's active Investigational New Drug (IND) applications."

Currently, Atara Biotherapeutics has one therapy (Tabelecleucel (tab-cel)) targeting the following condition: Post-Transplant Lymphoproliferative Disease (PTLD).

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:ATRA) was last updated on 7/10/2025 by MarketBeat.com Staff
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