30/09/2026 Atara Bio's partner Pierre Fabre Pharma, resubmits tab-cel BLA to FDA for EBV+ PTLD Celcuity Announces US Commercial Launch of REVTORPYK (gedatolisib) Atara Bio's partner Pierre Fabre Pharma, resubmits tab-cel BLA to FDA for EBV+ PTLD (Ref) Atara Biotherapeutics announced that its partner, Pierre Fabre Pharmaceuticals, has resubmitted the Biologics License Application (BLA) for tabelecleucel (tab-cel; allogeneic, off-the-shelf Epstein-Barr virus (EBV)-specific cyto

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

30/07/2026 NMPA grants priority review to sacituzumab tirumotecan for first‑line TNBC FDA Advisory Committee Backs RP1's Efficacy Data in Advanced Melanoma FDA Grants Orphan Drug Designation to Enzomenib for Acute Lymphoblastic Leukemia REVTORPYK (gedatolisib) Added to NCCN Guidelines for HR+/HER2- Breast Cancer Karyopharm to file sNDA in Aug 2026, for selinexor + ruxolitinib in Myelofibrosis under accelerated approval pathway Selinexor Phase 3 Endometrial cancer trial shows