From emerging therapies to earlier intervention and psychosocial support, Dermatology Times looks back at key alopecia areata developments in 2026.
News|Articles|September 29, 2026
Dermatology FDA and Pipeline Review: Q3 2026 Approvals and Readouts
The FDA approved therapies for melanoma, dermatomyositis, superficial basal cell carcinoma, and adolescent alopecia areata, while TYK2 inhibitors and rare disease filings advanced toward 2027 decisions.
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Welcome to the Dermatology Times quarterly FDA & Pipeline Review, a recurring look at the regulatory actions and drug development milestones shaping dermatology practice. Each installment tracks approvals, filings, and clinical data readouts against what they mean for patient care, not just what made headlines.
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The FDA approval, based on 36-week data from the phase 3 BRAVE-AA-PEDS trial, extends baricitinib access to patients as young as 12 years old with severe alopecia areata.
Week 28 data from the phase 2a EVERLAST-A trial showed PASI 100 responses increased to 71.4% despite no additional ORKA-001 dosing after week 4.
Takeda’s investigational oral TYK2 inhibitor is supported by phase 3 LATITUDE data demonstrating significant skin clearance versus placebo and apremilast.
Three experimental hair loss mechanisms are moving through late-stage trials for the first time in decades, and the data are worth knowing before patients ask.
Immunovant will discontinue development of imeroprubart in cutaneous lupus erythematosus after the phase 2b study failed to meet its primary endpoint.
Both barzolvolimab doses improved UAS7 at week 12 in EMBARQ-CSU1 and EMBARQ-CSU2, with up to 54% of patients reaching complete response by week 24.
The designation marks the first FDA Fast Track status granted to a therapy for peeling skin syndrome, which currently has no approved treatment.
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