Otsuka Pharmaceutical Europe and Lundbeck have announced that the European Commission has approved Rxulti (brexpiprazole) for ...
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 ...
Europe’s drug regulatory agency has given Kizfizo a negative opinion for the second time, following one from November 2024.
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.
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, 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 ...