Tag: EMA
CHMP Adopts Positive Opinion for Belantamab Mafodotin, Recommending Approval for the...
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of...
Environmental Risk Assessment and New Drug Development
1.0 Abstract
In our globalized world, human pharmaceutical residues and traces of other (chemical) down-the-drain contaminants have become an environmental concern. Following the detection of...
Phase I Trial Results in GBM Lead to Orphan Drug Designation...
The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have granted orphan drug designation to AbbVie's investigational compound ABT-414, an anti-epidermal growth factor receptor antibody drug conjugate, which is being evaluated for safety and efficacy in patients with glioblastoma multiform.