Otsuka Pharmaceutical Europe and Lundbeck have announced that the European Commission has approved Rxulti (brexpiprazole) for ...

Europe’s drug regulatory agency has given Kizfizo a negative opinion for the second time, following one from November 2024.

Orphelia Pharma is exploring alternative regulatory pathways for KIZFIZO after receiving a negative opinion from the ...

Uppsala University announced today that BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) two founders, Lars Lannfelt and Pär Gellerfors, ...

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.

Italfarmaco S.p.A. today announced a comprehensive update on the regulatory and clinical advancements for givinostat, the company’s drug for the treat ...

Regeneron Pharmaceuticals, Inc. REGN obtained positive opinion for its pipeline candidate linvoseltamab from the European ...

Leqembi’s application now moves forward to the European Commission, which will issue a formal verdict for the injection that ...

February brought policy updates and several biosimilar approvals, including the first FDA approval for an insulin aspart ...

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of ...

About Fabhalta® (iptacopan) Fabhalta (iptacopan) is an oral, Factor B inhibitor of the alternative complement pathway 6-7.

Right now, Rinvoq is approved in the European Union and the U.S. for the treatment of adults with radiographic axial ...