27/01/2026 Johnson & Johnson's DARZALEX FASPRO regimen has been approved in the US for multiple myeloma Imviva Biotech's CTD402 CAR-T received the FDA orphan drug designation for T-ALL/LBL Nanjing Leads Biolabs' LBL-034 received the FDA fast track designation for multiple myeloma Johnson & Johnson's DARZALEX FASPRO regimen has been approved in the US for multiple myeloma ( Ref ) The US FDA granted approval to Johnson & Johnson's DARZALEX FASPRO (daratumumab and hyaluronidase-

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

12/12/2025 Arcus and Gilead have discontinued the Phase 3 STAR-221 trial of their TIGIT regimen in gastric and esophageal cancers Johnson & Johnson's AKEEGA received FDA approval for BRCA2-mutated CSPC Arcus and Gilead have discontinued the Phase 3 STAR-221 trial of their TIGIT regimen in gastric and esophageal cancers ( Ref ) The Phase 3 STAR-221 trial of Arcus Biosciences and Gilead's domvanalimab (anti-TIGIT) + zimberelimab (anti-PD-1) + chemotherapy vs nivolumab + chemoth

07/12/2025 In Ph3 trial, Lilly's Jaypirca met its primary endpoint of ORR in CLL/SLL In Ph3 trial, Lilly's Jaypirca met its primary endpoint of ORR in CLL/SLL ( Ref ) The Phase 3 BRUIN CLL-314 trial of Eli Lilly and Company's pirtobrutinib (Jaypirca; BTK inhibitor) met its primary endpoint of non-inferiority on ORR vs ibrutinib in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who were treatment-naïve or were BTK inhibitor-naïve. ORR: 87.0%

17/11/2025 Dewpoint Therapeutics' DPTX3186 received the FDA fast track designation for gastric cancer ( Ref ) The US FDA granted the fast track designation to Dewpoint Therapeutics' DPTX3186 (oral condensate modulator) for the treatment of gastric cancer. Isaac Klein, CSO and Head of R&D, Dewpoint Therapeutics: “ We are honored that the FDA has recognized the urgency of gastric cancer and the promise of our condensate-based approach. DPTX3186 represents a new way of modulatin

26/08/2025 Genmab's Rina-S ADC received the Breakthrough Therapy Designation from the FDA for endometrial cancer ( Ref ) The US FDA...

07/08/2025 ProteinQure's PQ203 received the Fast track designation for TNBC ( Ref ) The US FDA granted the Fast Track designation to...

06/08/2025 Jazz Pharmaceuticals' Modeyso received accelerated approval from the FDA for Recurrent H3 K27M-mutant Diffuse Midline Glioma (...