Go or go go? J&J’s cell therapy heads to the FDA
November approval decisions loom for cilta-cel and Voxzogo, while molnupiravir heads for an advisory panel.
Has 2020 been a big year for regulatory knockbacks?
An analysis of FDA complete response letters does not reveal a big uptick – but the year is not over yet.
Go or no go? Valuable drugs set for FDA decisions
Upcoming US approval verdicts include inclisiran, valrox and risdiplam, but toxicity issues could scupper filgotinib.