17/12/2025 Incyte's Minjuvi® received the EC approval for treatment of R/R Follicular Lymphoma J&J's RYBREVANT FASPRO™ received the FDA approval for the treatment of EGFR-mutated NSCLC pharmaand GmbH's Rubraca received the FDA full approval for the treatment of BRCA mutant mCRPC Perioperative pembro + enfortumab vedotin elicited significant benefit in MIBC Incyte's Minjuvi® received the EC approval for treatment of R/R Follicular Lymphoma ( Ref ) The European Commission grant

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

August 3rd Week, 2025 Regulatory Events   🎯 Health Canada granted approval to Merck & Co./ MSD 's pembrolizumab (anti-PD-1) mono as a...

14/08/2025 Halda's HLD-0915 received the Fast Track Designation from the US FDA for mCRPC ( Ref ) The US FDA granted the Fast Track...

09/07/2025 Artera's ArteraAI Prostate received the Breakthrough Device designation from the US FDA ( Ref ) The US FDA granted the...

18/06/2025 The Phase 3 IDeate-Prostate01 trial of ifinatamab deruxtecan has been initiated in pretreated, metastatic CRPC patients ( Ref...

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