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bluebird bio (BLUE) FDA Events

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FDA Events for bluebird bio (BLUE)

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

bluebird bio's Drugs in FDA Review

Betibeglogene autotemcel (beti-cel) - FDA Regulatory Timeline and Events

Betibeglogene autotemcel (beti-cel) is a drug developed by bluebird bio for the following indication: Gene therapy in adult, adolescent and pediatric patients with transfusion-dependent β-thalassemia (TDT). 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.

Lovotibeglogene autotemcel (lovo-cel; formerly LentiGlobin) - FDA Regulatory Timeline and Events

Lovotibeglogene autotemcel (lovo-cel; formerly LentiGlobin) is a drug developed by bluebird bio for the following indication: Sickle Cell Gene Therapy. 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.

LYFGENIA - FDA Regulatory Timeline and Events

LYFGENIA is a drug developed by bluebird bio for the following indication: For patients with sickle cell disease who have a history of vaso-occlusive events (VOEs). 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.

bluebird bio FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, bluebird bio (BLUE) has reported FDA regulatory activity for the following drugs: LYFGENIA, Betibeglogene autotemcel (beti-cel) and Lovotibeglogene autotemcel (lovo-cel; formerly LentiGlobin).

The most recent FDA-related event for bluebird bio occurred on December 8, 2024, involving LYFGENIA. The update was categorized as "New Data," with the company reporting: "bluebird bio, Inc announced new and updated data from LYFGENIA™ (lovotobegligene autotemcel, or lovo-cel) gene therapy for patients with sickle cell disease who have a history of vaso-occlusive events (VOEs)."

Current therapies from bluebird bio in review with the FDA target conditions such as:

  • For patients with sickle cell disease who have a history of vaso-occlusive events (VOEs). - LYFGENIA
  • Gene therapy in adult, adolescent and pediatric patients with transfusion-dependent β-thalassemia (TDT) - Betibeglogene autotemcel (beti-cel)
  • Sickle Cell Gene Therapy - Lovotibeglogene autotemcel (lovo-cel; formerly LentiGlobin)

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:BLUE) was last updated on 7/11/2025 by MarketBeat.com Staff
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