Go or no go? Bristol's first-in-class hopes
April should mark the approval of some of the biggest drugs of 2022, including Alnylam's vutrisiran, while TG will hope to be spared pain at the PI3K adcom.
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.
Upcoming events – Avadel takes on Jazz and Axovant awaits early results
Data will soon show whether Avadel’s FT218 is more convenient than Jazz’s Xyrem, while Axovant will be looking for a dose response with its Parkinson’s gene therapy.
Go or no go? Vascepa’s finale and Allergan's pain relief
Amarin’s Vascepa and Allergan’s migraine project ubrogepant are the high-profile pending FDA approval decisions as the sector heads into the last month of the year.