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April User Fee Goal Calendar: Forecast Uncertain For Atopic Dermatitis Candidates, Nuplazid; Eohilia Could Be First For Orphan Use

 
• By Bridget Silverman

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.

Shutterstock - 661293361 Rain falling and colorful umbrella in rainy day
Sponsors could be showered with a range of approvals in April. • Source: Shutterstock

April could be a good month for people with atopic dermatitis, with US FDA decisions due on three applications – all hailing from the well-known JAK inhibitor class, two designated breakthrough therapies – unless emerging class safety concerns spur major amendments and consequent three-month extensions to the user fee goal date.

The expanding empire of JAK inhibitors in immune-mediated disease is poised to move into the large atopic dermatitis, or eczema,...

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