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Feb 26, 2026
Regeneron said the FDA accepted its garetosmab BLA for FOP and granted Priority Review, with a decision expected by August 2026. Phase 3 OPTIMA data reported major lesion reductions versus placebo.
Feb 21, 2026
Long-term data from the QUASAR extension study show TREMFYA® maintained clinical remission in over 80% of ulcerative colitis patients at Week 140, with more than half achieving endoscopic remission and no new safety concerns observed.
Feb 20, 2026
The FDA has accepted for Priority Review Regeneron's biologics license application for garetosmab to treat adults with fibrodysplasia ossificans progressiva, with a target action date of August 2026.
Feb 19, 2026
The FDA has accepted for Priority Review the Biologics License Application for garetosmab to treat adults with fibrodysplasia ossificans progressiva, with a target decision date of August 2026. The application is supported by Phase 3 OPTIMA trial data showing significant reductions in heterotopic bone lesions.
Feb 19, 2026
Ankyra Therapeutics announced preclinical data on ANK-203, a first-in-class anchored immunotherapy using monoclonal antibody CD137, showing strong anti-tumor activity with no observed systemic toxicity at the AACR Immuno-Oncology Conference.
Feb 18, 2026
CSL Limited has licensed global development and commercialization rights for clazakizumab to Eli Lilly outside of ESKD-related cardiovascular risk. CSL receives $100 million upfront and retains rights to the ESKD indication.
Feb 18, 2026
Phase 3b TOGETHER-PsO trial shows concomitant use of ixekizumab and tirzepatide delivered superior skin clearance and weight loss versus monotherapy in adults with moderate-to-severe plaque psoriasis and obesity or overweight.
Feb 17, 2026
MIT chemical engineers developed a large language model that optimizes codon sequences for protein production in industrial yeast, boosting efficiency for six proteins including human growth hormone and cancer antibodies.
Feb 16, 2026
A phase three clinical trial shows enlicitide, an oral monoclonal antibody, reduced LDL cholesterol by 60% compared to placebo in 2,909 patients with or at risk of atherosclerosis over 24 weeks.
Feb 13, 2026
Researchers at Icahn School of Medicine at Mount Sinai found that major depressive disorder shares key immune abnormalities with atopic dermatitis, particularly Th2 pathway activation. The team plans to test dupilumab in a clinical trial for depression.
Dec 30, 2025
Ultragenyx Pharmaceutical faces federal securities class action lawsuits following the failure of Phase 3 Orbit and Cosmic studies for setrusumab in Osteogenesis Imperfecta, with stock falling over 42% after December 2025 results announcement.
Feb 13, 2026
Lundbeck's investigational anti-PACAP antibody bocunebart demonstrated statistically significant reduction in monthly migraine days versus placebo in a phase IIb trial of patients who had failed prior preventive treatments, positioning the company for phase III discussions with regulators.
Feb 13, 2026
The European Commission has granted marketing authorization for Gotenfia, a golimumab biosimilar to Simponi, developed by Bio-Thera and to be commercialized by STADA across the EU, EEA, UK, Switzerland and selected other countries.
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.
