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Notizia - Recent Pharma, Healthcare and Biotech Happenings

Takeda’s MIMRYLO Wins U.S. FDA Approval for Polycythemia Vera; Lilly’s Mounjaro Gains FDA Approval for Cardiovascular Risk Reduction in Type 2 Diabetes; Teva Expands Neuroscience Portfolio Through Proposed Acquisition; BioNTech Ends Phase 2 Study of Autogene Cevumeran in Colorectal Cancer; AusperBio Secures $120 Million Series C to Advance AHB-137 and Next-Generation Hepatitis B Therapies

Takeda Gains FDA Approval for MIMRYLO Takeda announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for MIMRYLO™ (rusfertide) to treat erythrocytosis in adults with polycythemia vera (PV), a type of blood cancer. MIMRYLO is a first-in-class hepcidin mimetic developed to regulate iron distribution and excessive red blood cell production, thereby helping maintain hematocrit levels. Hematocrit refers to the proportion of red blood cells relative to the total volume of blood. Keeping hematocrit below 45% is a key treatment objective for patients with PV.1 According to Andrew T. Kuykendall, M.D., lead investigator of th...

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