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May 11, 2026
LIB Therapeutics launched Lerochol in the United States after FDA approval for lowering LDL-C in adults with hypercholesterolemia, including HeFH. The once-monthly PCSK9 inhibitor is available with a $199-per-month cash-pay option.
May 01, 2026
Aurobindo Pharma's subsidiaries secured Health Canada approval for bevacizumab biosimilar Bevqolva, an EU distribution deal with STADA for two EMA-approved biosimilars, and US FDA approval for ADQUEY ointment for atopic dermatitis.
Apr 11, 2026
Two phase 3 trials found upadacitinib 15 mg significantly improved facial and total repigmentation versus placebo at 48 weeks in nonsegmental vitiligo. The 614-patient studies also showed continued improvement over time and a safety profile consistent with prior use.
Apr 02, 2026
Phase 3 trial results show amlitelimab met primary endpoints in two monotherapy studies for moderate-to-severe atopic dermatitis, with combination therapy demonstrating the strongest efficacy. The investigational OX40L-targeting antibody showed comparable efficacy between every-4-week and every-12-week dosing intervals. Safety data revealed two cases of Kaposi sarcoma in patients with known risk factors among 4,630 exposed patients.
Mar 16, 2026
Two phase 3 trials demonstrate significant improvements in skin clearance and disease severity for children and adolescents with moderate-to-severe atopic dermatitis treated with targeted biologics.
Mar 09, 2026
The FDA has approved topical difamilast, a PDE4 inhibitor, for treating mild-to-moderate atopic dermatitis in adults and children aged 2 years or older, marking the third PDE4 inhibitor approval for this indication.
Feb 20, 2026
Eli Lilly's Omvoh demonstrated durable efficacy in Crohn's disease, with over 90% of patients maintaining steroid-free clinical remission through three years of monthly treatment in the Phase III VIVID-2 extension study.
Dec 22, 2025
The FDA approved multiple denosumab biosimilars in late 2025 and issued REMS safety updates emphasizing severe hypocalcemia risk in patients with advanced chronic kidney disease, including reported hospitalizations and fatalities.
