The CHMP recommends conditional marketing authorization of REGN's linvoseltamab to treat adults with relapsed and refractory multiple myeloma.

LEQEMBI (lecanemab) has significant market potential due to the high global prevalence of the condition and the demand for disease-modifying treatmen ...

Krystal Biotech receives positive CHMP opinion recommending the approval of Vyjuvek for treating dystrophic epidermolysis bullosa in the EU.

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

Eli Lilly and Company LLY announced that the European Medicines Agency's Committee for Medicinal Products for Human Use ...

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

The treatment has gained approval in the European Union (EU) for a range of conditions, including psoriatic arthritis, ...

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 ...