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) +...