Tolebrutinib had been provisionally approved in the United Arab Emirates in July 2025 for nrSPMS to slow disability accumulation independent of relapse activity
The approval makes AQVESME the only FDA-approved therapy for anemia in both non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia
U.S. and Canada transaction supports continued access to RADICAVA for people living with ALS
The study found that nerandomilast effectively slowed lung function decline in patients, with discontinuation rates similar to placebo
Full approval will depend on verification of clinical benefit in a confirmatory trial
The drug is designed to improve functional capacity and reduce symptoms by inhibiting cardiac myosin motor activity
The therapy also drove additional weight loss at the higher 1.8 mg dose without plateauing and maintained a favorable tolerability profile
FOP is a rare genetic disorder caused by mutations in the ALK2 kinase
The company also reported significant progress toward its internally defined Sustainable Development Goals
The initiative is focused on a problem that continues to plague cancer outcomes in India
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