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2seventy bio (TSVT) FDA Events

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FDA Events for 2seventy bio (TSVT)

This section highlights FDA-related milestones and regulatory updates for drugs developed by 2seventy bio (TSVT). Over the past two years, 2seventy bio has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Abecma. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Abecma (idecabtagene vicleucel) - FDA Regulatory Timeline and Events

Abecma (idecabtagene vicleucel) is a drug developed by 2seventy bio for the following indication: Relapsed and Refractory Multiple Myeloma. This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

2seventy bio FDA Events - Frequently Asked Questions

Yes, 2seventy bio (TSVT) has received FDA approval for Abecma (idecabtagene vicleucel). This page tracks recent and historical FDA regulatory events related to 2seventy bio's drug portfolio.

In the past two years, 2seventy bio (TSVT) has reported FDA regulatory activity for Abecma (idecabtagene vicleucel).

The most recent FDA-related event for 2seventy bio occurred on September 25, 2024, involving Abecma (idecabtagene vicleucel). The update was categorized as "Provided Update," with the company reporting: "2seventy bio, Inc announced that the Company, in partnership with study sponsor Bristol Myers Squibb (BMS), will discontinue enrollment in its ongoing Phase 3 KarMMa-9 study evaluating Abecma® (idecabtagene vicleucel; ide-cel) with lenalidomide maintenance versus lenalidomide maintenance alone in patients with newly diagnosed multiple myeloma (NDMM) who have suboptimal response to autologous stem cell transplant."

Currently, 2seventy bio has one therapy (Abecma (idecabtagene vicleucel)) targeting the following condition: Relapsed and Refractory Multiple Myeloma.

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:TSVT) was last updated on 7/10/2025 by MarketBeat.com Staff
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