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

20/01/2026 In the Ph2b KN-942 trial, Moderna and Merck's intismeran autogene + pembro showed sustained RFS benefit at 5 years of median follow-up Lilly's sofetabart mipitecan received the FDA Breakthrough Therapy designation for platinum-resistant ovarian cancer Celcuity's NDA for gedatolisib has been accepted for priority review for advanced breast cancer Lantern Pharma's LP-284 received the FDA orphan drug designation for soft tissue sarcomas In the Ph2b KN-942 trial, Moder