da Admin | Apr 27, 2021 | Other
https://ec.europa.eu In accordance with Commission Regulation, “similar medicinal product” means a medicinal product containing a similar active substance(s) as contained in an authorised orphan medicinal product and which is intended for the same...
da Admin | Apr 27, 2021 | Altro
https://ec.europa.eu In conformità con il regolamento CE, “un medicinale simile” indica un medicinale caratterizzato da una o più sostanze attive simili a quelle contenute in un medicinale orfano autorizzato, destinato alla stessa indicazione terapeutica....
da Admin | Mar 27, 2021 | Regulatory
https://www.pharmastar.it/ The U.S. Food and Drug Administration approved idecabtagene vicleucel (Abecma), a cell-based gene therapy to treat adult patients with multiple myeloma who have not responded to, or whose disease has returned after, at least four prior lines...
da Admin | Mar 27, 2021 | Regolatorio
https://www.pharmastar.it/ La Food and Drug Administration (FDA) ha concesso l’approvazione per idecabtagene vicleucel come prima terapia CAR T diretta contro l’antigene di maturazione delle cellule B per pazienti con mieloma multiplo recidivato/refrattario dopo 4 o...
