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

Krystal Biotech KRYS announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has ...

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 biosimilar.

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 ...

Vertex Pharmaceuticals (VRTX) stock in focus as company secures EU backing to expand label for its cystic fibrosis therapy ...

If granted, IXCHIQ® will become the first vaccine against the chikungunya virus (CHIKV) available in the EU for adolescents 12 years of age and ...

CHMP recommends approval of Regeneron's Lynozyfic, Krystal's Vyjuvek, Accord's trabectedin, Takeda's Deqsiga, and 16 label ...

Approval would expand the use of Enhertu to breast cancer patients with nearly undetectable HER2 levels in their tumors.

Krystal said it is on track to launch Vyjuvek in Germany in the middle of the year and in France later in 2025.

Biogen and Eisai said the European Medicines Agency's Committee for Medicinal Products for Human Use has reaffirmed its recommended approval of their Alzheimer's drug Leqembi.