Neurona Therapeutics Announces Priority Medicines (PRIME) Designation Granted by the European Medicines Agency (EMA) to NRTX-1001 in the Treatment of Drug-Resistant Focal Epilepsy

Neurona Therapeutics, a clinical-stage biotherapeutics company advancing regenerative cell therapies for disorders of the nervous system, today announced that its lead product candidate, NRTX-1001, ...

Arctic Therapeutics Receives EMA Approval for Phase IIa Study of AT-001 in Alzheimer's Disease

The European Medicines Agency (EMA) authorises initiation of a Phase IIa study evaluating AT-001 in patients diagnosed with Alzheimer's disease -- EMA grants Orphan Drug Designation (ODD) to AT-001 ...
Medscape

EMA Launches Review of Tecovirimat Effectiveness for Mpox

The European Medicines Agency (EMA) has initiated a review of Tecovirimat SIGA, also called TPOXX, a medicine used to treat mpox. This follows emerging clinical trial data suggesting a lack of ...
Reuters

EMA committee recommends approval for injectable version of Merck's Keytruda

Sept 19 (Reuters) - The European Medicines Agency's committee has recommended approval for a new formulation of Merck's (MRK.N), opens new tab blockbuster cancer therapy Keytruda that can be ...
Medscape

EMA Backs First Oral, On-Demand Treatment for Hereditary Angioedema

Editor's note: This article has been updated to note that this drug is the first oral on-demand drug for treating hereditary angioedema while Orladeyo (berotralstat) was the first oral treatment ...

Stonebranch Stands Out in 2025 EMA™ Radar Report with Value Leader Ranking and Event-Driven Orchestration Award

EMA spotlights Stonebranch UAC for innovation in orchestrating hybrid IT workflows with real-time triggers and embedded AI ...