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Results For "Committee-for-Medicinal-Products-for-Human-Use"

104 News Found

Roche receives positive CHMP opinion for Gavreto
Drug Approval | September 18, 2021

Roche receives positive CHMP opinion for Gavreto

If approved, Gavreto will be the first and only targeted treatment approved by the EMA that includes first-line treatment of people with RET fusion-positive advanced NSCLC


BMS receives positive CHMP opinion for Opdivo
Drug Approval | September 18, 2021

BMS receives positive CHMP opinion for Opdivo

The recommendation is based on positive results from the pivotal Phase 3 CheckMate -649 trial in which Opdivo plus chemotherapy demonstrated superior overall survival versus chemotherapy


Biocon and Viatris receive EC approval for Biosimilar Bevacizumab
Biotech | April 28, 2021

Biocon and Viatris receive EC approval for Biosimilar Bevacizumab

The drug is approved for the treatment in metastatic colorectal carcinoma, metastatic breast cancer and ovarian, cervical and renal cancer


Biocon Biologics and Viatris receive European Commission approval for Kixelle, Biosimilar Insulin Aspart
Biotech | February 13, 2021

Biocon Biologics and Viatris receive European Commission approval for Kixelle, Biosimilar Insulin Aspart

The centralized marketing authorization granted by the EC is valid in all EU Member