Keeping Track: US FDA Approves J&J’s Novel MS Drug Ponvory, Breakthrough Pericarditis Claim For Kiniksa’s Arcalyst
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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Zydus has established proof of concept for ZYIL1, a NLRP3 inflammasome inhibitor to treat cryopyrin-associated periodic syndromes, via Phase II trials in Australia. Will the oral drug have an upper hand over injectables like Novartis’ Ilaris?
The firm’s anti GM-CSF candidate has underwhelmed in a study in hospitalized COVID-19 patients, triggering renewed focus on its recently launched product Arcalyst for recurrent pericarditis.
April User Fee Goal Calendar: Forecast Uncertain For Atopic Dermatitis Candidates, Nuplazid; Eohilia Could Be First For Orphan Use
While some of the most prominent applications with user fee goal dates in April could be delayed, thanks to JAK inhibitor safety concerns and US FDA communications, the upcoming month should see more than 15 decisions on applications.