11/09/2026 Handa Secures final US FDA approval for OMCAZIO™ Cabozantinib capsules Immutep refocuses eftilagimod alfa development on PD-L1-negative (CPS <1) HNSCC and neoadjuvant STS following TACTI-004 discontinuation SERENA-4 Phase 3 trial of Etcamah + palbociclib missed its primary PFS endpoint in 1L ER+/ HER2- advanced breast cancer Handa Secures final US FDA approval for OMCAZIO™ Cabozantinib capsules (Ref) Handa Pharmaceuticals has received final US FDA approval for OMCA

26/08/2026 US FDA Fast Track designation granted for SOT106 in Soft Tissue Sarcoma; First-in-Human Trial Planned in late-2026 US FDA Fast Track designation granted for SYS6090 in MSS/pMMR metastatic colorectal cancer Celcuity submits sNDA to US FDA for approval of gedatolisib combination therapy in PIK3CA-mutant HR+/HER2- advanced breast cancer US FDA Fast Track designation granted for SOT106 in Soft Tissue Sarcoma; First-in-Human Trial Planned in late-2026 (Ref) The US FDA h

15/04/2026 FDA Grants Orphan Drug Status to Immutep’s Eftilagimod Alfa in Soft Tissue Sarcoma FDA Grants Fast Track to Opna Bio’s OPN-6602 for Relapsed/Refractory Multiple Myeloma FDA Grants Orphan Drug Status to Immutep’s Eftilagimod Alfa in Soft Tissue Sarcoma (Ref) Immutep’s lead candidate, eftilagimod alfa (efti), has received Orphan Drug Designation from the U.S. FDA for soft tissue sarcoma (STS), a rare cancer with high unmet need Supporting clinical data: Based on resu

09/10/2025 Adcendo's ADCE-D01 received the FDA fast track designation for the treatment of STS (Ref) The US FDA granted the fast track designation to Adcendo's ADCE-D01 (uPARAP-targeting ADC) for the treatment of soft tissue sarcoma (STS). Preclinically, ADCE-D01 shows strong anti-tumor activity in a range of mesenchymal tumor models including STS and is well tolerated in non-human primate toxicology studies with a favorable safety profile and no evidence of target-specific t

29/07/2025 Calidi Biotherapeutics' CLD-201 received the US FDA Fast Track Designation for soft tissue sarcoma (Ref) The US FDA granted the Fast Track designation to Calidi Biotherapeutics' CLD-201 (SuperNova; allogeneic adipose stem-cell loaded oncolytic virus) for the treatment of soft tissue sarcoma. Guy Travis Clifton, CMO, Calidi: “FDA IND clearance and Fast Track designation represents an important milestone in the development of CLD-201. This designation underscores the