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Keeping Track: US FDA Approves J&J’s Novel MS Drug Ponvory, Breakthrough Pericarditis Claim For Kiniksa’s Arcalyst

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The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

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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.

Janssen’s Newly Approved Ponvory Joins Crowded MS Space

Ponesimod is the fourth S1P modulator approved to treat multiple sclerosis and joins a sprawling class of oral and injectable therapies. But Janssen sees numerous ways to differentiate its drug.

Pfizer’s Xeljanz Could See Narrower Label And New REMS Due To CV And Malignancy Risks

The US FDA will ponder its regulatory options now that final data are in from a long-term postmarketing study showing tofacitinib is associated with a higher rate of major adverse cardiovascular events and malignancies compared with TNF-inhibitors.

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