02/06/2026 FDA accepts NDA and grants priority review to Roche’s giredestrant for early-stage ER+, HER2- breast cancer Candel’s CAN‑2409 Phase 3 in localized prostate cancer shows significant DFS benefit with favorable safety, supporting BLA filing in Q4 2026 Cycle Pharma secures FDA approval for CAVHANZA™, the first nilotinib ODT eliminating PPI/H₂RA timing restrictions to broaden Ph+ CML treatment flexibility FDA accepts NDA and grants priority review to Roche’s giredestran

01/06/2026 FDA grants Fast Track to Nouscom’s NOUS‑209, advancing the immunotherapy aimed at intercepting Lynch Syndrome‑associated cancers FDA grants Fast Track to Nouscom’s NOUS‑209, advancing the immunotherapy aimed at intercepting Lynch Syndrome‑associated cancers (Ref) NOUS‑209, an off‑the‑shelf cancer immunotherapy, received Fast Track status for preventing Lynch Syndrome (LS)‑associated cancers in carriers with mismatch repair mutations Phase 1b/2 data showed NOUS‑209

31/05/2026 Johnson & Johnson submits US sBLA for subcutaneous amivantamab in HPV-unrelated R/M HNSCC, previously treated with immunotherapy and chemotherapy Johnson & Johnson submits US sBLA for subcutaneous amivantamab in HPV-unrelated R/M HNSCC, previously treated with immunotherapy and chemotherapy (Ref) Johnson & Johnson confirmed that a supplemental Biologics License Application (sBLA) has been submitted to the US FDA seeking approval of subcutaneous amivantamab (EGFR x

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

13/05/2026 FDA grants Fast Track to SUPLEXA, advancing Alloplex’s non-engineered immune cell therapy for MSI-H colorectal cancer FDA grants Fast Track to SUPLEXA, advancing Alloplex’s non-engineered immune cell therapy for MSI-H colorectal cancer (Ref) The FDA has granted Fast Track Designation to SUPLEXA for treating colorectal cancer patients with the MSI-H phenotype Alloplex has submitted its US IND package for SUPLEXA in CRC-MSI-H and is advancing preparatory clinical act

12/05/2026 FDA grants Breakthrough Therapy Designation to Servier’s B7‑H4 ADC Emiltatug Ledadotin (Emi‑Le) for advanced adenoid cystic carcinoma Rigel secures global rights to VEPPANU, the first FDA‑approved oral PROTAC, with strong Phase 3 data in ER+/HER2‑, ESR1‑mutated breast cancer ZUSDURI delivers 64.5% 3‑year event‑free durability in recurrent LG‑IR‑NMIBC FDA grants Breakthrough Therapy Designation to Servier’s B7‑H4 ADC Emiltatug Ledadotin (Emi‑Le) for advanced adenoid

11/05/2026 FDA grants Fast Track to Zai Lab’s DLL3‑targeting ADC Zocilurtatug Pelitecan (Zoci) for epNECs Hansoh Pharma’s HS-20093 B7-H3 ADC wins NMPA Breakthrough Therapy nod in ESCC Innovent’s IBI363 secures third Breakthrough Therapy Designation in China, advancing to Phase III for MSS/pMMR colorectal cancer with Takeda partnership FDA grants Fast Track to Zai Lab’s DLL3‑targeting ADC Zocilurtatug Pelitecan (Zoci) for epNECs (Ref) Zai Lab's : Zocilurtatug pelitecan (Zoci,

08/05/2026 FDA grants RMAT designation to RZ-001, Algenomics’ RNA-based gene therapy for hepatocellular carcinoma, accelerating U.S. development and global partnership opportunities Sacituzumab tirumotecan + pembrolizumab gains NMPA priority review after landmark Phase III success in first‑line PD‑L1+ NSCLC FDA grants RMAT designation to RZ-001, Algenomics’ RNA-based gene therapy for hepatocellular carcinoma, accelerating U.S. development and global partnership opportunities

07/05/2026 Pierre Fabre secures FDA alignment to resubmit tabelecleucel BLA with updated ALLELE Phase 3 data for EBV+ PTLD Halozyme Announces Global Collaboration and License Agreement with GSK for the first ADC-focused ENHANZE, targeting subcutaneous oncology formulations and milestone-driven royalties Pierre Fabre secures FDA alignment to resubmit tabelecleucel BLA with updated ALLELE Phase 3 data for EBV+ PTLD (Ref) Pierre Fabre Pharmaceuticals (PFP) aligned with the FDA o

06/05/2026 FDA grants Fast Track designation to Diakonos Oncology’s DOC1021 immunotherapy for advanced melanoma, advancing a novel dendritic cell therapy into Phase 1/2 trials Partner Therapeutics secures FDA Priority Voucher for BIZENGRI in NRG1+ cholangiocarcinoma, advancing rapid review of Phase 2 eNRGy data FDA accepts sNDA for IBTROZI® with >4‑year median response in ROS1+ NSCLC, reinforcing long‑term efficacy and global standard‑of‑care potential FDA grants Fast Track d

28/04/2026 FDA accepts NDA for zipalertinib in EGFR exon 20–mutated NSCLC; PDUFA set for Feb 2027 FDA Grants RMAT Designation to Orca-Q, Advancing Precision Cell Therapy for High-Risk Hematologic Malignancies Scancell’s iSCIB1+ secures FDA Fast Track with 77% PFS, Phase 3 initiation anticipated in H2 2026 for advanced Melanoma Henlius secures EU approval for POHERDY® (pertuzumab biosimilar), expanding global oncology footprint FDA accepts NDA for zipalertinib in EGFR exon 20–

27/04/2026 Zanidatamab combinations receive the FDA priority review status for HER2+ GEA; PDUFA date of Aug'26 set Tovecimig + paclitaxel significantly improved PFS and ORR in biliary tract cancer; sBLA submission planned FDA Grants Breakthrough Therapy Designation to TERN-701 in Chronic Myeloid Leukemia Relay Therapeutics Advances PI3Kα/CDK4 Triplet Toward Frontline Breast Cancer Phase 3 Trial Zanidatamab combinations receive the FDA priority review status for HER2+ GEA; PDU

14/04/2026 FDA Grants Fast Track to Daretabart for High‑Risk Neuroblastoma FDA sBLA Submission & NCCN Guideline Inclusion for BIZENGRI in NRG1 Fusion–Positive Cholangiocarcinoma Obsidian Therapeutics and Galera Therapeutics Announce Merger Agreement to advance OBX-115 TIL Therapy FDA Grants Fast Track to Daretabart for High‑Risk Neuroblastoma ( Ref ) Renaissance Pharma's Daretabart (hu1418K322A), a novel anti-GD2 monoclonal antibody, has received Fast Track status from the U.

09/04/2026 NMPA Accepts NDA for DB-1303/BNT323 in HER2+ Metastatic Breast Cancer Celltrion Wins Dual FDA Fast Track Approvals for ADC Pipeline Satri-cel: First CAR-T Therapy for Solid Tumors Set to Launch in China NMPA Accepts NDA for DB-1303/BNT323 in HER2+ Metastatic Breast Cancer ( Ref ) The New Drug Application (NDA) for DualityBio and BioNTech's DB-1303/BNT323 (Trastuzumab Pamirtecan, T-Pam; HER2‑targeted ADC) has been accepted by China’s National Medical Products Admini

08/04/2026 FDA Grants Orphan Drug Status to Plus Therapeutics’ REYOBIQ™ for Pediatric Malignant Gliomas FDA Grants Orphan Drug Designation to Compass Therapeutic’s Tovecimig for Biliary Tract Cancer FDA Grants Orphan Drug Status to Plus Therapeutics’ REYOBIQ™ for Pediatric Malignant Gliomas ( Ref ) Plus Therapeutics’ REYOBIQ™ (rhenium Re186 obisbemeda) has been granted orphan drug status for pediatric malignant gliomas, with scope expanded to include pediatric ependymoma Regu

02/04/2026 Merck & Co./MSD's pembrolizumab + paclitaxel ± bevacizumab received the EC approval for Platinum-Resistant Recurrent Ovarian Carcinoma Context Therapeutics' CTIM-76 received the FDA fast track designation for platinum-resistant ovarian cancer AstraZeneca's Phase 3 EMERALD-3 trial met the PFS endpoint in embolisation-eligible unresectable HCC Merck & Co./MSD's pembrolizumab + paclitaxel ± bevacizumab received the EC approval for Platinum-Resistant Recurrent Ovarian

31/03/2026 Caribou Biosciences' CB-011 received the FDA RMAT designation for multiple myeloma Caribou Biosciences' CB-011 received the FDA RMAT designation for multiple myeloma ( Ref ) The US FDA granted the Regenerative Medicine Advanced Therapy (RMAT) designation to Caribou Biosciences' CB-011 (allogeneic anti-BCMA CAR-T) for relapsed or refractory multiple myeloma (r/r MM). The cell therapy is b eing evaluated in the open-label, multicenter Phase 1 CaMMouflage clinical tri

24/03/2026 The Ph3 SENTRY trial of Karyopharm's selinexor + ruxolitinib met SVR35 but not Abs-TSS endpoint in frontline myelofibrosis ReCerise's RCT1213 received the FDA ODD for hepatocellular carcinoma The Ph3 SENTRY trial of Karyopharm's selinexor + ruxolitinib met SVR35 but not Abs-TSS endpoint in frontline myelofibrosis ( Ref ) Karyopharm Therapeutics reported topline results from its Phase 3 SENTRY trial of selinexor 60 mg + ruxolitinib in frontline myelofibrosis. The tr

17/03/2026 CRISM Therapeutics' irinotecan received the FDA ODD for malignant glioma Voro Therapeutics and Daiichi Sankyo sign a research collaboration for Next-Generation Tumor-Activated ADCs Myriad Genetics' MyChoice CDx test received FDA approval as the companion diagnostic for Zejula CRISM Therapeutics' irinotecan received the FDA ODD for malignant glioma ( Ref ) The US FDA granted the Orphan Drug Designation to CRISM Therapeutics Corporation's irinotecan for the treatment

12/03/2026 Aminex Therapeutics' AMXT 1501 received the FDA ODD for Glioma Aminex Therapeutics' AMXT 1501 received the FDA ODD for Glioma ( Ref ) The US FDA granted the orphan drug designation to Aminex Therapeutics' AMXT 1501 (polyamine transport inhibitor) + difluoromethylornithine for the treatment of malignant glioma, including diffuse intrinsic pontine glioma (DIPG). The Beat Childhood Cancer Research Consortium at Penn State College of Medicine, in partnership with Amine