Keeping Track: US FDA Approves Zokinvy, Defers Liso-Cel, Declines ALKS 3831 And Zimhi; Two Biosimilars Filed
The latest drug developments news and highlights from the Pink Sheet’s US FDA Performance Tracker
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Keeping Track: US FDA Clears Pfizer’s Prevnar 20; Dermavant Submits Tapinarof; Adamis Returns With Zimhi
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Other expected generics include Viatris' Perforomist (formoterol fumarate), Pfizer's Sutent (sunitinib), Sanofi's Jevtana (cabazitaxel) and possibly Boehringer Ingelheim's Pradaxa.
The review of liso-cel, Celgene/Bristol Myers Squibb's potential new CAR T-cell therapy for R/R DLBCL, is facing regulatory setbacks in the EU as well as in the US.