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Seagen (SGEN) FDA Events

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FDA Events for Seagen (SGEN)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Seagen (SGEN). Over the past two years, Seagen has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as ADCETRIS, KEYNOTE-A39, and Tisotumab. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Seagen's Drugs in FDA Review

ADCETRIS - FDA Regulatory Timeline and Events

ADCETRIS is a drug developed by Seagen for the following indication: Prescription medicine directed against the CD30 protein. 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.

KEYNOTE-A39 - FDA Regulatory Timeline and Events

KEYNOTE-A39 is a drug developed by Seagen for the following indication: For the treatment of metastatic urothelial 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.

Tisotumab Vedotin - FDA Regulatory Timeline and Events

Tisotumab Vedotin is a drug developed by Seagen for the following indication: Recurrent or Metastatic 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.

Seagen FDA Events - Frequently Asked Questions

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

In the past two years, Seagen (SGEN) has reported FDA regulatory activity for the following drugs: ADCETRIS, Tisotumab Vedotin and KEYNOTE-A39.

The most recent FDA-related event for Seagen occurred on February 12, 2025, involving ADCETRIS. The update was categorized as "FDA Approval," with the company reporting: "Pfizer Inc announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for ADCETRIS® (brentuximab vedotin) in combination with lenalidomide and a rituximab product for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are not eligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or chimeric antigen receptor (CAR) T-cell therapy."

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

  • Prescription medicine directed against the CD30 protein - ADCETRIS
  • Recurrent or Metastatic Cervical Cancer - Tisotumab Vedotin
  • For the treatment of metastatic urothelial cancer - KEYNOTE-A39

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