Shilpa Medicare & mAbTree Biologics win FDA nod for rare blood cancer therapy
The pioneering monoclonal antibody is for Essential Thrombocythemia (ET) and Polycythemia Vera (PV), rare chronic blood cancers with limited treatment options
The pioneering monoclonal antibody is for Essential Thrombocythemia (ET) and Polycythemia Vera (PV), rare chronic blood cancers with limited treatment options
Waskyra is an ex vivo gene therapy that uses patients’ own CD34+ hematopoietic stem and progenitor cells, genetically engineered with a lentiviral vector
The investigational subcutaneous hepcidin mimetic peptide is designed to regulate iron and red blood cell production
The resubmission of BLA for MOLBREEVI names Fujifilm as the drug substance manufacturer
The interim efficacy readout, involving around 170 participants with 15-month data, remains on track for the end of March 2026
The drug had previously received orphan drug designation for this rare cancer on March 31, 2025
Wayrilz represents a new approach to ITP by targeting the disease at its root through multi-immune modulation
Efdoralprin alfa, a recombinant human alpha-1 antitrypsin (AAT)-Fc fusion protein, showed superior efficacy to standard plasma-derived therapy in adults with AATD
The funding will support the pivotal Phase 3 clinical trial of neridronate in CRPS-1
GSK holds exclusive global rights (excluding mainland China, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to advance its development and commercialization
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