Merck receives positive European Union CHMP opinion for Gefapixant
The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorization in the European Union
The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorization in the European Union
The positive CHMP opinion is supported by results from the Phase III QUASAR trial
WINREVAIR is currently the first and only activin signalling inhibitor approved for PAH across all 27 EU member states
The audit was completed with zero critical and zero major observations
It's a development that marks a major step forward for patients struggling with moderate-to-severe chronic spontaneous urticaria
AVT03 is a biosimilar of Amgen's Prolia (denosumab 60 mg/mL) and Xgeva (denosumab 70 mg/mL), which are used to treat various bone conditions
This is the first drug to receive a recommendation for this preventative indication in the European Union
OncoMate MSI Dx Analysis System is a PCR-based assay designed to evaluate MSI status in tumor tissue
The approval granted with zero supplementation requests is an important milestone in Glenmark’s respiratory pipeline
Subscribe To Our Newsletter & Stay Updated