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.
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.
LEO Pharma has closed its acquisition of dersimelagon from Tanabe Pharma after the FDA accepted the drug's NDA for filing and granted Priority Review, with a PDUFA date expected by the end of February 2027.
Sol-Gel Technologies has completed patient follow-up in its pivotal phase 3 trial of SGT-610 (patidegib gel, 2%) for Gorlin syndrome, with top-line results expected in late November 2026.
The FDA has set a PDUFA target action date of June 29, 2027, based on APEX trial data showing a 65% overall response rate in advanced systemic mastocytosis.