Alvotech advances dual Entyvio biosimilar strategy as FDA accepts subcutaneous AVT80 application
FDA accepts Alvotech’s AVT80 application for a subcutaneous Entyvio biosimilar, expanding its vedolizumab strategy alongside Teva.
FDA accepts Alvotech’s AVT80 application for a subcutaneous Entyvio biosimilar, expanding its vedolizumab strategy alongside Teva.
The U.S. Food and Drug Administration has approved once-weekly MIMRYLO, or rusfertide, for erythrocytosis in adults with polycythemia vera, introducing the first therapy designed to mimic the iron-regulating hormone hepcidin.
BP-205 Phase 1 data show a 25-hour half-life and support once-daily dosing as Harmony advances its orexin agonist into further clinical testing.
Polpharma Biologics’ PB016 enters FDA and EMA review, adding a new vedolizumab biosimilar challenge to Takeda’s Entyvio franchise.
Discover how Takeda’s $600 million Insilico Medicine collaboration could reshape AI drug discovery, candidate design and clinical translation.