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

PrimeC has been given an ‘Orphan Drug’ status by the FDA (Food and Drug Administration) and EMA (European Medicines Agency).

The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended three novel medicines for approval at its ...

Developed by Johnson & Johnson, guselkumab (GUS) is the first approved fully-human, dual-acting IL-23p19 subunit inhibitor that blocks IL-23 and binds to CD64, a receptor on cells that produce IL-23.

If approved, this off-the-shelf, fixed-duration Columvi combination will be the first bispecific antibody regimen available for patients with DLBCL following relapse ...

Incyte (Nasdaq: INCY) today announced that multiple abstracts featuring new data from its dermatology portfolio will be presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting, ...

A key regulatory win could turn this under-the-radar treatment into AbbVie's next billion-dollar success story.

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

Regeneron Pharmaceuticals (NASDAQ:REGN) said the European Medicines Agency’s Committee for Medicinal Products for Human Use ...

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

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

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