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

NewAmsterdam Pharma's obicetrapib lowers LDL-C in Phase 3 trials, showing promise as a CETP inhibitor. Read more on NAMS ...

Vertex Pharmaceuticals (NASDAQ:VRTX) announced Friday that an expert panel of the EU drug regulator, the European Medicines ...

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

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended the approval of Vyjuvek for the ...

Krystal Biotech (KRYS) has received a positive recommendation from EU regulators for its drug Vyjuvek for the treatment of ...

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

The European Union's medicines regulator on Friday reiterated its positive recommendation for Eisai and Biogen's Alzheimer's ...

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

The European Commission had requested the committee consider new data on the drug that became available after it had adopted its positive opinion.

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.

Following a flurry of activity at this month’s meeting of the European Medicines Agency’s Committee for Medicinal Products ...