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Genmab A/S (GMAB) FDA Approvals

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Genmab A/S's Drugs in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Genmab A/S (GMAB). Over the past two years, Genmab A/S has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as epcoritamab, Epcoritamab, EPKINLY®, Rina-S, TEPKINLY, Tisotumab, and TIVDAK. 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.

Epcoritamab FDA Regulatory Timeline and Events

Epcoritamab is a drug developed by Genmab A/S for the following indication: To-Treat Relapsed/Refractory Follicular Lymphoma. 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.

Epcoritamab (DuoBody-CD3xCD20) FDA Regulatory Events

Epcoritamab (DuoBody-CD3xCD20) is a drug developed by Genmab A/S for the following indication: Follicular Lymphoma (FL). 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.

EPKINLY® (epcoritamab-bysp) FDA Regulatory Timeline and Events

EPKINLY® (epcoritamab-bysp) is a drug developed by Genmab A/S for the following indication: To Treat Patients with Relapsed or Refractory Follicular Lymphoma. This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Rina-S FDA Regulatory Timeline and Events

Rina-S is a drug developed by Genmab A/S for the following indication: In Heavily Pretreated Patients with Ovarian and Endometrial Cancers. 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.

TEPKINLY FDA Regulatory Events

TEPKINLY is a drug developed by Genmab A/S for the following indication: For the Treatment of Adults with Relapsed/Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL). 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 Events

Tisotumab Vedotin is a drug developed by Genmab A/S 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.

TIVDAK FDA Regulatory Events

TIVDAK is a drug developed by Genmab A/S for the following indication: For Patients with 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.

Genmab A/S FDA Events - Frequently Asked Questions

Yes, Genmab A/S (GMAB) has received FDA approval for EPKINLY® (epcoritamab-bysp). This page tracks recent and historical FDA regulatory events related to Genmab A/S's drug portfolio.

In the past two years, Genmab A/S (GMAB) has reported FDA regulatory activity for the following drugs: Rina-S, epcoritamab, EPKINLY® (epcoritamab-bysp), TIVDAK, Epcoritamab (DuoBody-CD3xCD20), Tisotumab Vedotin and TEPKINLY.

The most recent FDA-related event for Genmab A/S occurred on August 26, 2025, involving Rina-S. The update was categorized as "Designation Grant," with the company reporting: "Genmab A/S announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to rinatabart sesutecan (Rina-S®), an investigational folate receptor alpha (FRα)-directed, TOPO1-inhibitor antibody-drug conjugate (ADC), for the treatment of adult patients with recurrent or progressive endometrial cancer (EC) who have disease progression on or following prior treatment with a platinum-containing regimen and a PD-(L)1 therapy."

Current therapies from Genmab A/S in review with the FDA target conditions such as:

  • In Heavily Pretreated Patients with Ovarian and Endometrial Cancers - Rina-S
  • To-Treat Relapsed/Refractory Follicular Lymphoma - epcoritamab
  • To Treat Patients with Relapsed or Refractory Follicular Lymphoma - EPKINLY® (epcoritamab-bysp)
  • For Patients with Recurrent or Metastatic Cervical Cancer - TIVDAK
  • Follicular Lymphoma (FL) - Epcoritamab (DuoBody-CD3xCD20)
  • Recurrent or Metastatic Cervical Cancer - Tisotumab Vedotin
  • For the Treatment of Adults with Relapsed/Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL) - TEPKINLY

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:GMAB) was last updated on 8/28/2025 by MarketBeat.com Staff
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