Home Regulatory Regulatory Updates

Regulatory Updates

Regulatory updates

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...