pharmaphorum4d
When measuring European regulatory approval, the timestamp matters
specifically in comparing approval regulatory cycles for the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Last year we wrote a three-part series, "Life in the Fast ...
Business Wire29d
European Medicines Agency Validates Gilead’s Marketing Authorization Application and EU-Medicines for All Application for Twice-Yearly Lenacapavir for HIV Prevention
--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Medicines Agency (EMA ... interest in how this medication, if approved, could help transform efforts ...
MercoPress27d
Novavax added to COVID-19 immunizers approved for European use
The US-developed NOVAVAX vaccine against COVID-19 has been approved Monday by the European Medicines Agency (EMA), thus becoming the fifth drug of its kind to become available at a continental level.
Finanznachrichten12d
H. Lundbeck A/S: Rxulti (brexpiprazole) approved in the European Union for the treatment of schizophrenia in adolescents aged 13 years and older
Brexpiprazole's indication for the treatment of schizophrenia in adults is extended to include adolescents aged 13 years and older 1 Approval ... from the European Medicines Agency in January ...