PharmaTimes2d
Rxulti approved in the European Union for adolescent schizophrenia
Otsuka Pharmaceutical Europe and Lundbeck have announced that the European Commission has approved Rxulti (brexpiprazole) for ...
pharmaphorum3d
When measuring European regulatory approval, the timestamp matters
The EMA's drug approval process is a two-step process, consisting of both the CHMP and EC's decisions. In comparison, the FDA is the only body that conducts regulatory review in the United States ...
GlobalData on MSN3d
Orphelia explores avenues for liquid neuroblastoma med after EU CHMP rejection
Europe’s drug regulatory agency has given Kizfizo a negative opinion for the second time, following one from November 2024.
Zacks.com on MSN4d
IONS/AZN Get FDA Nod for Amyloidosis Drug, Wainzua in Europe
The latest decision makes Ionis/AstraZeneca's Wainzua the only approved drug in the EU for ATTRv-PN that can be self-administered monthly via an auto-injector.
pharmaphorum1d
Novo Nordisk nears EU okay for oral GLP-1 drug Rybelsus after CHMP nod
The CHMP has issued a positive opinion for the ... the globally dominant cause of cholera. If approved by the EMA, Vaxchora will be the only single-dose oral vaccine indicated for active ...
NanoViricides Not Affected by Tariffs and Other Policies, Has Excellent Long Term Outlook, Stock-Price Decline Misguided, Explains the Company
NanoViricides, Inc. (the “Company”)(NYSE American:NNVC), a clinical-stage global leader developing revolutionary broad-spectrum antiviral drugs that the viruses cannot escape, declared today that its ...