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Biogen (BIIB) FDA Events

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FDA Events for Biogen (BIIB)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Biogen (BIIB). Over the past two years, Biogen has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as BIIB080/IONIS-MAPT, dapirolizumab, Felzartamab, Lecanemab, LEQEMBI®, nusinersen, and salanersen. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Biogen's Drugs in FDA Review

BIIB080/IONIS-MAPT - FDA Regulatory Timeline and Events

BIIB080/IONIS-MAPT is a drug developed by Biogen for the following indication: Mild Alzheimer's disease. 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.

dapirolizumab pegol - FDA Regulatory Timeline and Events

dapirolizumab pegol is a drug developed by Biogen for the following indication: In Systemic Lupus Erythematosus. 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.

Felzartamab - FDA Regulatory Timeline and Events

Felzartamab is a drug developed by Biogen for the following indication: For the Treatment of Antibody-Mediated Rejection in Kidney Transplant Recipients. 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.

Lecanemab (BAN2401) - FDA Regulatory Timeline and Events

Lecanemab (BAN2401) is a drug developed by Biogen for the following indication: Anti-amyloid beta (Aβ) protofibril antibody for the treatment of Alzheimer's disease (AD). 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.

LEQEMBI® (lecanemab-irmb) - FDA Regulatory Timeline and Events

LEQEMBI® (lecanemab-irmb) is a drug developed by Biogen for the following indication: Treatment of Alzheimer's Disease. 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.

nusinersen - FDA Regulatory Timeline and Events

nusinersen is a drug developed by Biogen for the following indication: In Treatment of spinal muscular atrophy (SMA). 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.

salanersen - FDA Regulatory Timeline and Events

salanersen is a drug developed by Biogen for the following indication: For the treatment of spinal muscular atrophy (SMA). 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.

SPINRAZA (Nusinersen) - FDA Regulatory Timeline and Events

SPINRAZA (Nusinersen) is a drug developed by Biogen for the following indication: Spinal muscular atrophy (SMA). This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

TOFIDENCE - FDA Regulatory Timeline and Events

TOFIDENCE is a drug developed by Biogen for the following indication: For the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis. 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.

Biogen FDA Events - Frequently Asked Questions

Yes, Biogen (BIIB) has received FDA approval for SPINRAZA (Nusinersen). This page tracks recent and historical FDA regulatory events related to Biogen's drug portfolio.

In the past two years, Biogen (BIIB) has reported FDA regulatory activity for the following drugs: LEQEMBI® (lecanemab-irmb), nusinersen, Felzartamab, dapirolizumab pegol, SPINRAZA (Nusinersen), Lecanemab (BAN2401), salanersen, BIIB080/IONIS-MAPT and TOFIDENCE.

The most recent FDA-related event for Biogen occurred on June 30, 2025, involving Felzartamab. The update was categorized as "Dosing Update," with the company reporting: "Biogen Inc. announced the initiation of dosing in the global clinical study, PROMINENT."

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

  • Treatment of Alzheimer's Disease - LEQEMBI® (lecanemab-irmb)
  • In Treatment of spinal muscular atrophy (SMA). - nusinersen
  • For the Treatment of Antibody-Mediated Rejection in Kidney Transplant Recipients - Felzartamab
  • In Systemic Lupus Erythematosus - dapirolizumab pegol
  • Spinal muscular atrophy (SMA) - SPINRAZA (Nusinersen)
  • Anti-amyloid beta (Aβ) protofibril antibody for the treatment of Alzheimer's disease (AD) - Lecanemab (BAN2401)
  • For the treatment of spinal muscular atrophy (SMA). - salanersen
  • Mild Alzheimer's disease - BIIB080/IONIS-MAPT
  • For the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis. - TOFIDENCE

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