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Results For "European-Union"

224 News Found

Merck receives positive European Union CHMP opinion for Gefapixant
News | July 22, 2023

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


EMA backs Eylea 8 mg for retinal vein occlusion
News | December 13, 2025

EMA backs Eylea 8 mg for retinal vein occlusion

The positive CHMP opinion is supported by results from the Phase III QUASAR trial


Merck wins key EU backing to expand use of PAH Drug WINREVAIR
News | December 13, 2025

Merck wins key EU backing to expand use of PAH Drug WINREVAIR

WINREVAIR is currently the first and only activin signalling inhibitor approved for PAH across all 27 EU member states


Innoxel Lifesciences completes EU GMP inspection by Belgium's FAMHP
Drug Approval | November 29, 2025

Innoxel Lifesciences completes EU GMP inspection by Belgium's FAMHP

The audit was completed with zero critical and zero major observations


EU greenlights Dupixent for chronic urticaria, offering new hope to patients
Drug Approval | November 27, 2025

EU greenlights Dupixent for chronic urticaria, offering new hope to patients

It's a development that marks a major step forward for patients struggling with moderate-to-severe chronic spontaneous urticaria


Dr Reddy’s receives EU nod for AVT03 biosimilar denosumab
News | November 24, 2025

Dr Reddy’s receives EU nod for AVT03 biosimilar denosumab

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


EMA recommends authorization of Teizeild to delay Type 1 diabetes onset
Drug Approval | November 17, 2025

EMA recommends authorization of Teizeild to delay Type 1 diabetes onset

This is the first drug to receive a recommendation for this preventative indication in the European Union


FDA approves Promega’s OncoMate test to guide personalised treatment for endometrial cancer
Drug Approval | November 14, 2025

FDA approves Promega’s OncoMate test to guide personalised treatment for endometrial cancer

OncoMate MSI Dx Analysis System is a PCR-based assay designed to evaluate MSI status in tumor tissue


Glenmark secures China approval for Ryaltris
Drug Approval | November 10, 2025

Glenmark secures China approval for Ryaltris

The approval granted with zero supplementation requests is an important milestone in Glenmark’s respiratory pipeline