Novo Nordisk plans to file for regulatory approval of the 25mg and 50mg dosage strengths in 2023.
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Treatment with dupilumab led to a significant 30% reduction in moderate or severe acute COPD exacerbations.
Tofersen is an investigational antisense medicine that reduces the synthesis of SOD1 protein production.
Rezzayo is expected to be available in the summer of 2023.
Solanezumab is a humanized monoclonal antibody designed to increase clearance of soluble amyloid beta (Aβ) from the brain by binding to aggregated forms of Aβ.
Valoctocogene roxaparvovec is an investigational adeno-associated virus (AAV) gene therapy.
The FDA is requiring the Company to conduct an additional clinical trial evaluating omecamtiv mecarbil for HFrEF.
The application is supported by data from a phase 3 study evaluating niraparib plus AAP as first-line treatment in patients with mCRPC with or without alterations in HRR associated genes.
TTX-MC138 is designed to inhibit the pro-metastatic RNA, microRNA-10b, and eliminate metastasis.
The sBLA is supported by data from the phase 3 CheckMate -76K trial which included 790 patients after complete resection of stage IIB or IIC melanoma.