Regeneron and Sanofi announce the FDA has approved Dupixent® (dupilumab) for adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) whose disease is not adequately controlled with H1 antihistamines, making Dupixent the first biologic approved for CSU in over a decade.
Bristol Myers Squibb announces FDA approval of Breyanzi® (lisocabtagene maraleucel; liso-cel) for adults with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy, expanding Breyanzi's indications to a fifth B-cell malignancy.
Pfizer announces that the Phase 3 MagnetisMM-9 trial evaluating elranatamab (Elrexfio®) plus standard-of-care in transplant-ineligible newly diagnosed multiple myeloma met its primary endpoint of progression-free survival, potentially expanding elranatamab's use to the frontline setting.
AstraZeneca announces FDA approval of Tagrisso® (osimertinib) for unresectable Stage III EGFR-mutated non-small cell lung cancer following concurrent platinum-based chemoradiation therapy, based on the landmark Phase 3 LAURA trial demonstrating an 84% reduction in disease progression risk.
GRAIL announces a favorable vote from the FDA's Molecular and Clinical Genetics Devices Panel for the Premarket Approval of the Galleri® multi-cancer early detection test (MCED), with the committee voting 7–2 that benefits outweigh risks for adults aged 50 and older.
Astellas Pharma announces the first patient has been dosed in a Phase 3 study evaluating setidegrasib, a novel investigational KRAS G12D-targeted protein degrader, versus docetaxel in previously treated patients with advanced NSCLC — marking the second Phase 3 study of setidegrasib initiated within six months.
Novo Nordisk announces Singapore's Health Sciences Authority (HSA) has approved Wegovy® (once-weekly injectable semaglutide 2.4 mg) as the first approved treatment in Singapore for adults with noncirrhotic MASH and moderate to advanced liver fibrosis (F2–F3), based on ESSENCE Phase 3 trial data showing 63% vs 34% steatohepatitis resolution.
Lantheus Holdings announces FDA final approval for BRAVNETSA™ (lutetium Lu 177 dotatate), the only radiopharmaceutical the FDA has determined to be bioequivalent and therapeutically equivalent to LUTATHERA® for treatment of adult patients with somatostatin receptor-positive GEP-NETs.
IntraBio Inc. announces FDA approval of AQNEURSA® (levacetylleucine) for the treatment of ataxia in patients with ataxia-telangiectasia (A-T), marking the first and only approved treatment for A-T anywhere in the world.
Roche reports positive Phase 2 results for its Carmot-derived GLP-1/GIP dual agonist asset, demonstrating significant HbA1c reduction and meaningful weight loss in adults with type 2 diabetes, advancing the compound toward Phase 3 development.
