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
Mage Biologics to develop a monoclonal antibody targeting ulcerative colitis
Deal includes DTx-1252, a potential therapy for the neuromuscular disorder Charcot-Marie-Tooth disease type 1A (CMT1A), and two additional preclinical programs for other neuroscience indications
Evonik specializes in mid- to large-scale, later clinical phase HPAPIs
Approval to dramatically change CAR-T therapies landscape
The inspection closed with the facility receiving an inspection classification of NAI
The inspection closed with zero observations
The company will submit its comprehensive response on these observations to the US FDA
Total investments could reach €70 million, of which approximately 15% in R&D and 85% in capex, that would be deployed from 2026
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