The approval makes AQVESME the only FDA-approved therapy for anemia in both non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia
The trial will evaluate the efficacy and safety of IPX203 versus immediate-release levodopa/carbidopa
The study is being conducted under a USFDA IND, has received U.S. Fast Track Designation for SLE-ITP, and has obtained IND approval from China’s Center for Drug Evaluation
The new powder formulation gives children and adults living with Rett syndrome greater flexibility and choice in dose volume and taste
Adverse events were similar to placebo, and no AP-101-induced antibody responses were detected
The study met its primary endpoint and all 11 secondary efficacy endpoints
While Merck can appeal, Halozyme said it expects the order to hold
The partnership aims to combine TQx’s in vivo therapeutic expertise with Kytopen’s continuous flow transfection technology
The clearance for TELLTALE positions Transmural Systems at the forefront of next-generation electrosurgical solutions for structural heart interventions
Renalyx will continue operating as an independent unit within the group
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