Genmab, Inc.
New Jersey
United States
36 articles about Genmab, Inc.
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U.S. FDA Accepts for Priority Review the Supplemental Biologics License Application for Epcoritamab (EPKINLY®) for Difficult-to-Treat Relapsed or Refractory Follicular Lymphoma
2/27/2024
U.S. FDA Accepts for Priority Review the Supplemental Biologics License Application for Epcoritamab (EPKINLY ® ) for Difficult-to-Treat Relapsed or Refractory Follicular Lymphoma.
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Genmab Publishes 2023 Annual Report
2/14/2024
Genmab A/S announced the publication of its Annual Report for 2023.
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Genmab Announces Initiation of Share Buy-Back Program
2/14/2024
Genmab A/S announced that it is initiating a share buy-back program to honor our commitments under our Restricted Stock Unit program.
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Tisotumab Vedotin Marketing Authorization Application Validated by European Medicines Agency for Treatment of Recurrent or Metastatic Cervical Cancer
2/2/2024
Genmab A/S (Nasdaq: GMAB) and Pfizer, Inc. (NYSE PFE) today announced that the European Medicines Agency (EMA) has validated for review the marketing authorization application (MAA) of tisotumab vedotin, an antibody-drug conjugate (ADC), developed for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy.
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TIVDAK® Supplemental Biologics License Application Accepted for Priority Review by FDA for Patients with Recurrent or Metastatic Cervical Cancer
1/9/2024
Pfizer Inc. (NYSE: PFE) and Genmab A/S (Nasdaq: GMAB) announced today that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) seeking to convert the accelerated approval of TIVDAK® (tisotumab vedotin-tftv) to full approval, for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy.
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Johnson & Johnson and Genmab revealed the first data from a Phase III study of a Darzalex Faspro-based quadruplet therapy in patients with transplant-eligible newly diagnosed multiple myeloma.
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ASH Preview: Darzalex Faspro in Multiple Myeloma, Imbruvica-Venclexta in Mantle Cell Lymphoma
11/22/2023
J&J, AbbVie, Genmab and Genentech are presenting new data at next month’s American Society of Hematology meeting on the therapeutic potential of their therapies in multiple myeloma and mantle cell lymphoma. -
Traverse Biotech announces a world-wide license agreement with Genmab to develop and commercialize a novel cancer bispecific antibody
9/12/2023
Traverse Biotech announces that it has signed a license agreement Genmab under which Traverse will develop and commercialize a bispecific antibody for cancer immunotherapy. This next-generation antibody was created using Genmab's proprietary DuoBody® bispecific antibody technology platform as a targeted treatment candidate for cancers expressing an undisclosed tumor-associated antigen.
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The companies are moving closer to traditional approval for the antibody-drug conjugate Tivdak, which met its primary endpoint for overall survival in an interim analysis.
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Genmab Announces Financial Results for the First Half of 2023
8/3/2023
The U.S. FDA approval of EPKINLY as the first bispecific antibody to treat adults with relapsed or refractory DLBCL was an important milestone both for Genmab and for patients in need of an innovative treatment option administered subcutaneously.
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Phase I/II data on AbbVie and Genmab’s recently approved bi-specific antibody in a second cancer indication positions them to talk to regulators about filings to challenge Roche’s Lunsumio.
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With Friday’s approval, Epkinly edges out Roche’s bi-specific antibody glofitamab, which is also being proposed for diffuse large B-cell lymphoma.
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The FDA has four events lined up this week, including a target action date for Krystal Biotech's gene therapy for a rare skin disease and an adcomm meeting for Pfizer’s RSV vaccine candidate.
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AbbVie and Genmab announced positive topline results from their Phase I/II trial for lymphoma treatment; Sanofi posted positive results from its Phase I/II trial for the treatment of ITP.
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Janssen Pharmaceutical, under parent organization Johnson & Johnson, secured an arbitrary win this week that results in royalty decisions stemming from licensing and marketing of daratumumab.
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The FDA places holds, companies receive clearance for new studies and Pharma giants release new data in last week's clinical trial news.
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It earned the FDA's green light after its Phase II innovaTV 204 clinical trial delivered stellar results in terms of tumor response and durability of the response.
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It was based on data from the APOLLO trial showing the drug significantly decreased the risk of progression or death by 37% compared to dexamethasone alone.
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Reminder: Ligand to Host Analyst Day on March 12th in New York City
2/21/2019
Event to feature business updates and presentations by four corporate partners
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iDD biotech receives second milestone payment from Genmab with enrollment of fifth patient in GEN1029 (HexaBody®-DR5/DR5) safety trial in patients with malignant solid tumors
12/4/2018
iDD biotech reports that it has received a second milestone payment after its partner, Genmab, started a Phase I/IIa trial of GEN1029 (HexaBody-DR5/DR5).