Orca Bio’s Orca-T FDA review extended to July 2026

Merck strikes $6.7 billion deal to acquire terns, bolstering cancer pipeline

TERN-701, a next-generation therapy targeting chronic myeloid leukemia (CML), a form of blood cancer that still presents treatment challenges despite decades of advances

Shilpa Biologicals and mAbTree Biologics secure ODD from USFDA

Marks significant milestone for breakthrough biologic to treat rare blood cancers

ExCellThera’s Zemcelpro scores big in Germany, paving way for early hospital access

The therapy, also known as UM171 Cell Therapy, recently received conditional marketing authorization from the European Commission

Zydus receives USFDA ODD for Desidustat for the treatment of sickle cell disease

This Orphan Drug Designation from the USFDA underlines the urgent medical need to develop a therapy for sickle cell disease

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

AGC Biologics powers commercial launch of its life-changing gene therapy for rare childhood immune disorder

Waskyra is an ex vivo gene therapy that uses patients’ own CD34+ hematopoietic stem and progenitor cells, genetically engineered with a lentiviral vector

Takeda & Protagonist submit FDA application for groundbreaking polycythemia vera therapy

The investigational subcutaneous hepcidin mimetic peptide is designed to regulate iron and red blood cell production

Savara resubmits FDA application for potential treatment in rare lung disease patients

The resubmission of BLA for MOLBREEVI names Fujifilm as the drug substance manufacturer

Diamyd Medical accelerates Phase 3 Type 1 diabetes trial following FDA guidance

The interim efficacy readout, involving around 170 participants with 15-month data, remains on track for the end of March 2026