Agios Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for mitapivat in sickle cell disease (SCD) and granted Priority Review, establishing a PDUFA target…
The European Commission approved TEPKINLY (epcoritamab) in combination with lenalidomide and rituximab (R2) for adults with relapsed or refractory follicular lymphoma. The approval is supported by the Phase 3 EPCORE FL-1 trial, where TEPKINLY…
Fate Therapeutics announced that preliminary clinical data from the systemic sclerosis arm of its Phase 1 FT819 basket trial will be presented at ISSCR 2026. The first four treated systemic sclerosis patients showed clinical…
China’s NMPA approved CARsgen’s satri-cel, the first CAR-T therapy approved anywhere in the world for a solid tumor.
Be Biopharma terminated the Phase 1/2 BeCoMe-9 study of BE-101, the first engineered B cell medicine tested clinically in hemophilia B.
Intellia reported additional positive Phase 3 data for lonvoguran ziclumeran (lonvo-z) in hereditary angioedema, reinforcing earlier primary endpoint success and strengthening the regulatory profile of one of the most advanced in vivo CRISPR programs…
Syndax presented interim real-world evidence from the ROAR study at EHA 2026 showing an 82% overall response rate and 64% CR/CRh rate among heavily pretreated patients with relapsed or refractory NPM1-mutated or KMT2A-rearranged acute…
Sobi presented new clinical and real-world evidence across four rare hematology franchises at EHA 2026: PNH (pegcetacoplan), ITP (avatrombopag), HLH (emapalumab), and myelofibrosis (pacritinib). While no pivotal efficacy readouts were disclosed, the package reinforces…
Johnson & Johnson presented pivotal ENERGY Phase 2/3 data showing statistically significant durable hemoglobin responses for IMAAVY in warm autoimmune hemolytic anemia, supporting its February 2026 sBLA filing.
Climb Bio presented the first clinical data for budoprutug, an anti-CD19 monoclonal antibody, in primary immune thrombocytopenia (ITP). Early Phase 1b results demonstrated robust B-cell depletion, encouraging safety, and meaningful platelet responses in heavily…
