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.
Regulatory rejection flurry does not make a storm
Fears of heightened scrutiny by the FDA will be calmed by a look at historic rates of complete response letters.
Go or no go? UCB bids to make a mark in psoriasis
Chemocentryx and Avadel will also see important FDA regulatory action this month, while Omeros gets another delay.
Amylyx changes its mind about an early filing
The group hopes phase 2 data will back approval for its amyotrophic lateral sclerosis project AMX0035 after all.
