FDA nod to Bristol Myers Squibb’s Sotyktu as new oral therapy for psoriatic arthritis
The FDA decision was based on results from the pivotal POETYK PsA-1 and POETYK PsA-2 Phase 3 trials
The FDA decision was based on results from the pivotal POETYK PsA-1 and POETYK PsA-2 Phase 3 trials
Sotyktu continues to demonstrate consistent efficacy and safety across rheumatic conditions
The submission is supported by results from the Phase 3b APEX study
Apremilast Tablets, 10 mg, 20 mg, and 30 mg is a generic equivalent of reference listed drug (RLD) OTEZLA of Celgene.
UCB plans to submit regulatory applications in Q3 2022
BLA is based on a robust data package supporting similarity to Orencia (abatacept) IV for infusion through totality of evidence including pharmacokinetic (PK) data
This is the first controlled pharmacologic study to demonstrate that treatment of obesity improved PsA disease measures
Takeda said zasocitinib was generally well tolerated, with a safety profile consistent with earlier studies
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