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Regeneron Pharmaceuticals (REGN) FDA Approvals

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Regeneron Pharmaceuticals' Drugs in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Regeneron Pharmaceuticals (REGN). Over the past two years, Regeneron Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Aflibercept, Dupixent, EYLEA, itepekimab, Libtayo, Linvoseltamab, and linvoseltamab-gcpt. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Select a button below to view the list of FDA events for that drug.

Aflibercept FDA Regulatory Timeline and Events

Aflibercept is a drug developed by Regeneron Pharmaceuticals for the following indication: For the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR). 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.

Dupixent (dupilumab) FDA Regulatory Timeline and Events

Dupixent (dupilumab) is a drug developed by Regeneron Pharmaceuticals for the following indication: Moderate-to-severe asthma. This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

EYLEA (aflibercept) FDA Regulatory Timeline and Events

EYLEA (aflibercept) is a drug developed by Regeneron Pharmaceuticals for the following indication: Wet age-related macular degeneration (wet AMD). 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.

Itepekimab FDA Regulatory Events

Itepekimab is a drug developed by Regeneron Pharmaceuticals for the following indication: For Chronic Obstructive Pulmonary 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.

Libtayo (cemiplimab) FDA Regulatory Timeline and Events

Libtayo (cemiplimab) is a drug developed by Regeneron Pharmaceuticals for the following indication: Advanced Cervical Cancer. 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.

Linvoseltamab (BCMAxCD3) FDA Regulatory Timeline and Events

Linvoseltamab (BCMAxCD3) is a drug developed by Regeneron Pharmaceuticals for the following indication: Designed to bridge B-cell maturation antigen (BCMA) on multiple myeloma cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing. 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.

Linvoseltamab-gcpt FDA Regulatory Events

Linvoseltamab-gcpt is a drug developed by Regeneron Pharmaceuticals for the following indication: For Treatment of Relapsed or Refractory Multiple Myeloma. 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.

NTLA-2001 FDA Regulatory Timeline and Events

NTLA-2001 is a drug developed by Regeneron Pharmaceuticals for the following indication: Transthyretin (ATTR) Amyloidosis. 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.

Odronextamab FDA Regulatory Timeline and Events

Odronextamab is a drug developed by Regeneron Pharmaceuticals for the following indication: To treat adult patients with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), who have progressed after at least two prior systemic therapies. 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.

Pozelimab FDA Regulatory Events

Pozelimab is a drug developed by Regeneron Pharmaceuticals for the following indication: It is an IgG4 antibody that binds with high affinity to wild-type and variant human C5. 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.

Sarilumab FDA Regulatory Events

Sarilumab is a drug developed by Regeneron Pharmaceuticals for the following indication: for the Treatment of Active Polyarticular Juvenile Idiopathic Arthritis (pJIA). 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.

Semaglutide (GLP-1 receptor agonist) FDA Regulatory Events

Semaglutide (GLP-1 receptor agonist) is a drug developed by Regeneron Pharmaceuticals for the following indication: induced Weight Loss by Preserving Lean Mass. 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.

Regeneron Pharmaceuticals FDA Events - Frequently Asked Questions

Yes, Regeneron Pharmaceuticals (REGN) has received FDA approval for Dupixent (dupilumab). This page tracks recent and historical FDA regulatory events related to Regeneron Pharmaceuticals' drug portfolio.

In the past two years, Regeneron Pharmaceuticals (REGN) has reported FDA regulatory activity for the following drugs: Dupixent (dupilumab), Linvoseltamab (BCMAxCD3), Libtayo (cemiplimab), EYLEA (aflibercept), Aflibercept, NTLA-2001, Odronextamab, Semaglutide (GLP-1 receptor agonist), linvoseltamab-gcpt, itepekimab, Pozelimab and sarilumab.

The most recent FDA-related event for Regeneron Pharmaceuticals occurred on July 30, 2025, involving Libtayo (cemiplimab). The update was categorized as "Clinical Data," with the company reporting: "Sensei Biotherapeutics, Inc that clinical data from the dose expansion cohort of the Phase 1/2 trial of solnerstotug alone and in combination with Libtayo® (cemiplimab), Regeneron's PD-1 inhibitor, will be presented in a mini oral session at the European Society for Medical Oncology (ESMO) Congress 2025, being held October 17-21, 2025 in Berlin, Germany.."

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

  • Moderate-to-severe asthma - Dupixent (dupilumab)
  • Designed to bridge B-cell maturation antigen (BCMA) on multiple myeloma cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing. - Linvoseltamab (BCMAxCD3)
  • Advanced Cervical Cancer - Libtayo (cemiplimab)
  • Wet age-related macular degeneration (wet AMD) - EYLEA (aflibercept)
  • For the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR), - Aflibercept
  • Transthyretin (ATTR) Amyloidosis - NTLA-2001
  • To treat adult patients with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), who have progressed after at least two prior systemic therapies. - Odronextamab
  • induced Weight Loss by Preserving Lean Mass - Semaglutide (GLP-1 receptor agonist)
  • For Treatment of Relapsed or Refractory Multiple Myeloma - linvoseltamab-gcpt
  • For Chronic Obstructive Pulmonary Disease - itepekimab
  • It is an IgG4 antibody that binds with high affinity to wild-type and variant human C5. - Pozelimab
  • for the Treatment of Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) - sarilumab

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:REGN) was last updated on 8/2/2025 by MarketBeat.com Staff
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