Plenty Of Action On EU Accelerated Assessment Front
A number of companies have sought to convince the European Medicine Agency that their drug merits a fast-track regulatory review.
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October and November 2020 were bad months for companies seeking to have their planned EU filings fast-tracked through the centralized drug review system at the European Medicines Agency.
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.
Among the 13 new drug marketing applications that the European Medicines Agency has most recently accepted for review are two products that could become the first approved treatments for children with progressive familial intrahepatic cholestasis, a life-threatening disorder.