Drug Approval | March 13, 2026
Shilpa Biologicals and mAbTree Biologics secure ODD from USFDA
Marks significant milestone for breakthrough biologic to treat rare blood cancers
Marks significant milestone for breakthrough biologic to treat rare blood cancers
The designation for HCB101covers all forms of gastric cancer, including advanced gastric adenocarcinoma in both HER2-positive and HER2-negative patients
This Orphan Drug Designation from the USFDA underlines the urgent medical need to develop a therapy for sickle cell disease
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
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