15/06/2026 Midstage Pancreatic Cancer Study Fails to Meet Primary Endpoint but Will Advance to Phase 3 FDA accepts ozekibart BLA, setting April 2027 PDUFA for conventional Chondrosarcoma Halia Therapeutics Secures FDA Fast Track Designation for Ofirnoflast in Lower-Risk MDS Menarini Group's Phase 3 SENTRY trial met its first co-primary endpoint, with the selinexor + ruxolitinib combination achieving significant improvement in spleen volume reduction (SVR35) vs ruxolitinib alo

28/05/2026 FDA grants Priority Review to Cogent’s bezuclastinib + sunitinib combo in GIST RenovoRx secures FDA Orphan Drug Designation for oxaliplatin in pancreatic cancer Enterome’s EO2463 secures FDA Orphan Drug Designation for indolent NHL FDA grants Priority Review to Cogent’s bezuclastinib + sunitinib combo in GIST (Ref) FDA accepted Cogent’s New Drug Application (NDA) for bezuclastinib + sunitinib in imatinib-pretreated GIST, granting Priority Review with a PDUFA date o

19/05/2026 Cullinan’s CLN‑049 earns FDA Orphan Drug Designation in relapsed/refractory AML FL118 Receives Dual FDA Designations for Osteosarcoma, Advancing Rare Pediatric Cancer Treatment Cullinan’s CLN‑049 earns FDA Orphan Drug Designation in relapsed/refractory AML (Ref) LN-049, a novel FLT3 x CD3 T cell engager, has received Orphan Drug Designation for relapsed/refractory acute myeloid leukemia (AML) CLN-049 is in Phase 1 trials, including multiple ascending dose studies i

16/05/2026 ImPact Biotech’s padeliporfin VTP delivers 70% complete response with durable safety in Phase 3 LG‑UTUC, setting up 2027 regulatory submission and expansion into solid tumors ImPact Biotech’s padeliporfin VTP delivers 70% complete response with durable safety in Phase 3 LG‑UTUC, setting up 2027 regulatory submission and expansion into solid tumors (Ref) Biotech’s updated Phase 3 ENLIGHTED trial data for padeliporfin VTP in low‑grade upper tract urothelial carcinoma

12/01/2026 Novita Pharmaceuticals' NP-G2-044 received the FDA orphan drug designation for pancreatic cancer Eureka Therapeutics' ECT204 received the FDA RMAT designation for hepatocellular carcinomaEureka Therapeutics' ECT204 received the FDA RMAT designation for hepatocellular carcinoma Summit Therapeutics submitted a BLA seeking approval for ivonescimab + chemo in 2L+ EGFRm NSCLC AbbVie acquires ex-China rights to RemeGen's RC148 in a ~$5.6B deal Novita Pharmaceuticals' NP-

January 1st Week, 2026 Clinical Events 🔬 Per primary analysis from the Phase 3 HERIZON-GEA-01 trial, Jazz Pharmaceuticals , BeOne Medicines and Zymeworks Inc. 's zanidatamab (bispecific HER2-directed antibody) + chemo ± BeOne Medicines ' tislelizumab (anti-PD-1) met the PFS endpoint as a first-line treatment of HER2+, locally advanced or metastatic gastroesophageal adenocarcinoma. (Ref 1) ❓ What are the current survival benchmarks for this indication? Special Designatio

07/01/2026 Arbele's ARB1002 received the FDA orphan drug designation for pancreatic cancer Curadel Pharma's CPI-008 imaging drug received the FDA and EMA orphan drug designation for pancreatic cancer Arbele's ARB1002 received the FDA orphan drug designation for pancreatic cancer ( Ref ) The US FDA granted the orphan drug designation to Arbele's ARB1002 (CDH17 targeting ADC) for the treatment of pancreatic cancer. Dr Linda Wu, CDO, Arbele: " Orphan Drug Designation for ARB10

27/10/2025 Cellectar Biosciences' iopofosine I131 received the rare pediatric drug designation for pediatric high-grade glioma ( Ref ) The US FDA granted the rare pediatric drug designation (RPDD) to Cellectar Biosciences' iopofosine I131 in inoperable R/R pediatric high-grade glioma (pHGG). The FDA previously granted Orphan Drug Designation for iopofosine I 131 for the treatment of pHGG James Caruso, President and CEO, Cellectar: “ Receiving Rare Pediatric Disease Designatio

September 4th Week, 2025 Regulatory Events 🎯 The US FDA approved Eli Lilly and Company 's imlunestrant (oral estrogen receptor...

25/09/2025 Eli Lilly and Company's Inluriyo has been approved in the US for ER+, HER2–, ESR1-mutated breast cancer ( Ref ) The US FDA...

20/08/2025 Invion's INV043 received the FDA's Orphan Drug Designation for anal cancer ( Ref ) The US FDA granted the Orphan Drug...

July 4th Week, 2025 Regulatory Events 🎯 The EC approved Bayer and Orion Pharma ’s darolutamide (androgen receptor inhibitor) +...

24/07/2025 GenFleet Therapeutics and Verastem Oncology's VS-7375 received the Fast Track Designation from the US FDA for pancreatic...

July 2nd Week, 2025 Regulatory Updates 🎯 The EC approved BeOne Medicines ' tislelizumab (anti-PD-1) + gemcitabine + cisplatin for the...

10/07/2025 TEVIMBRA + chemotherapy has been approved in EU as a first-line treatment for NPC ( Ref ) The EC approved BeOne Medicines'...

30/06/2025 Revolution Medicines and Summit entered into a clinical collaboration to evaluate RAS(ON) inhibitors and ivonescimab...

June 3rd Week , 2025 Regulatory Events 🎯 The US FDA approved the updated labelling of Pfizer ’s talazoparib (PARP inhibitor) +...