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
The company is pursuing the accelerated FDA 505(b)(2) approval pathway for its once-daily oral ondansetron formulation
Illexcor is developing a first-in-class oral drug that directly targets the root cause of SCD
Under the deal, Hims & Hers will offer patients access to FDA-approved versions of Ozempic and Wegovy at the same self-pay prices available through other telehealth platforms
The interim results of the Phase 3 SUCCESSOR-2 study's safety profile aligned with expectations for both mezigdomide and the combination regimen
The oral therapy is aimed at adults with chronic spontaneous urticaria (CSU) who do not respond adequately to H1-antihistamines
The NDA filing is supported by results from the phase III evERA Breast Cancer study
Achondroplasia is a genetic condition driven by FGFR3 that affects more than stature alone
The therapy was well tolerated through Week 24, with a safety profile consistent with Alumis’ Phase 2 data
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