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 ...
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 ...
Medscape

EMA Questions Valproate Prescribing Restrictions for Men

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has announced it is assessing new data on the potential risk of neurodevelopmental disorders (NDDs) in ...