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Regulatory

Cetuximab Saratolacan Approved in Japan for the Treatment of Unresectable Locally Advanced and Recurrent...

Japan’s Ministry of Health, Labour and Welfare has approved cetuximab saratolacan sodium (previously known as RM-1929; Akalux® IV Infusion...

European Commission Grants Conditional Marketing Authorization to GSK for the Use of Belantamab Mafodotin...

The European Commission has granted conditional marketing authorization* for the use of GlaxoSmithKline's anti-B-cell maturation antigen (BCMA) therapy belantamab...

U.S. FDA Approves Belantamab Mafodotin as a Monotherapy in R/R Multiple Myeloma

The U.S. Food and Drug Administration has approved* belantamab mafodotin-blmf (Blenrep®; GlaxoSmithKline/GSK) as a monotherapy treatment for adult patients...

CHMP Adopts Positive Opinion for Belantamab Mafodotin, Recommending Approval for the Treatment of R/R...

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive...

Advisory Committee Votes in Favor of Positive Benefit/Risk Profile for Belantamab Mafodotin in R/R...

The U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) has voted 12-0 in favor of positive...

FDA Lifts Partial Clinical Hold on Pivotal Phase II Clinical Trial of Camidanlumab Tesirine

Earlier this week the U.S. Food and Drug Administration (FDA) lifted a partial clinical hold on the pivotal Phase...
Photo: Photo ASCO meeting. Photo Courtesy: ASCO/Todd Buchanan 2015

ASCO 2020 – Promising Development in the Advancement of Antibody-drug Conjugates

With an increasing number of antibody-drug conjugates (ADC) being approved and commercially available for the treatment of patients with...
Featured Image: Women and the power to fight breast cancer Courtesy: © 2017. Fotolia. Used with permission.

Trastuzumab deruxtecan Launced in Japan for Patients with HER2 Positive Unresectable or Metastatic Breast...

This week Daiichi Sankyo announced the launch of trastuzumab deruxtecan (Enhertu®), a HER2 directed antibody-drug conjugate (ADC), in Japan. The...
Daiichi Sankyo

Daiichi Sankyo Submits Supplemental New Drug Application for Trastuzumab Deruxtecan in Japan for HER2...

In a statement earlier today, Daiichi Sankyo confirmed that it has submitted a supplemental New Drug Application (sNDA) to...

Everest Medicines’ Licensing Partner Immunomedics Receives FDA Accelerated Approval for Sacituzumab Govitecan for the...

Everest Medicines' U.S.-based licensing partner Immunomedics earlier today confirmed that the U.S. Food and Drug Administration (FDA) has approved...