07/07/2026 ITM‑11 significantly outperforms everolimus in advanced GEP‑NETs with superior efficacy and safety ITM‑11 significantly outperforms everolimus in advanced GEP‑NETs with superior efficacy and safety (Ref) ITM announced that primary results from its Phase 3 COMPETE trial were published in The Lancet, showing that investigational ¹⁷⁷Lu-edotreotide (ITM-11; SSTR2-targeted peptide receptor radionuclide therapy) significantly improved progression-free survival and respon

02/07/2026 Roche's Divarasib demonstrates superiority over approved KRAS G12C Inhibitors in Phase 3 NSCLC trial Roche's Divarasib demonstrates superiority over approved KRAS G12C Inhibitors in Phase 3 NSCLC trial (Ref) Roche's Phase 3 Krascendo 1 study of divarasib (next-generation KRAS G12C inhibitor) demonstrated statistically significant improvements in both progression-free and overall survival vs approved first generation KRAS G12C inhibitors sotorasib or adagrasib in pa

26/06/2026 Henlius’ serplulimab secures EU approval for sqNSCLC FDA accepts RP1 BLA resubmission for advanced Melanoma; Decision expected by August 2026 FDA grants tentative approval for enzalutamide tablets, adding new dosing strengths to compete with Xtandi Henlius’ serplulimab secures EU approval for sqNSCLC (Ref) The European Commission approved serplulimab (Hetronifly®; anti-PD-1) in combination with chemotherapy for first-line treatment of unresectable locally advanced

24/06/2026 US FDA approved sacituzumab govitecan-hziy as monotherapy and in combination with pembrolizumab for first-line treatment of triple-negative breast cancer (TNBC) EU approves KEYTRUDA + Padcev as first PD-1 + ADC perioperative regimen for cisplatin-ineligible MIBC IBRANCE secures US FDA approval as the first CDK4/6 inhibitor for HR+, HER2+ metastatic breast cancer maintenance US FDA approved sacituzumab govitecan-hziy as monotherapy and in combination with pembrolizu

17/06/2026 Avenacy Launches Bortezomib for Injection in the U.S., Marking Its 28th Product Since Inception Avenacy Launches Bortezomib for Injection in the U.S., Marking Its 28th Product Since Inception (Ref) Avenacy has officially launched Bortezomib for Injection in the US, a generic equivalent of VELCADE® indicated for adults with multiple myeloma and mantle cell lymphoma The product is available as a 3.5 mg single-dose vial and features Avenacy's differentiated packaging

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

03/06/2026 Terremoto Biosciences Secures FDA Fast Track for AKT1‑Selective Inhibitor TER‑2013 in HR+/HER2– Breast Cancer FDA grants Orphan Drug Designation to Sotio’s LRRC15-targeted ADC SOT106 for osteosarcoma, advancing toward first-in-human trial in 2H26 Lupin & Natco secure FDA approval for Eribulin generic, unlocking $43.7M U.S. market opportunity Verastem’s VS-7375 secures FDA Fast Track for KRAS G12D-mutated NSCLC Amtagvi® (lifileucel) wins conditional TGA approval as

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

May 3rd Week, 2026 Regulatory Events 🎯 Shanghai Junshi Biosciences Co Ltd’s NDA for toripalimab (anti-PD-1) + RemeGen Biosciences’ disitamab vedotin (HER2 ADC) for patients with HER2-expressing LA/M urothelial carcinoma was approved by the NMPA. (Ref 1) ❓ What are the clinical outcomes that support this approval? Special Designations ⭐ The US FDA granted the Priority Review status to Bayer’s sevabertinib (HER2 TKI) for the first-line treatment of adult patients with LA/M

21/05/2026 Junshi Biosciences secures NMPA approval for toripalimab + disitamab vedotin in HER2+ urothelial carcinoma Kelun-Biotech's Phase III sac-TMT Trial meets Primary PFS Endpoint in First-Line Advanced TNBC Junshi Biosciences secures NMPA approval for toripalimab + disitamab vedotin in HER2+ urothelial carcinoma (Ref) China’s NMPA approved toripalimab + disitamab vedotin for first-line treatment of HER2-expressing locally advanced or metastatic urothelial carcinoma (UC)

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

18/05/2026 Sacituzumab tirumotecan (Sac‑TMT) delivers survival benefit in advanced endometrial cancer, meeting OS and PFS endpoints over chemotherapy FDA grants Priority Review to Bayer’s HYRNUO® (sevabertinib) for first-line treatment of HER2-mutated NSCLC Sacituzumab tirumotecan (Sac‑TMT) delivers survival benefit in advanced endometrial cancer, meeting OS and PFS endpoints over chemotherapy (Ref) The Phase 3 TroFuse-005 study of sacituzumab tirumotecan (Sac‑TMT), a TROP2-d

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

15/05/2026 FDA approved ENHERTU (fam-trastuzumab deruxtecan-nxki) for the treatment of neoadjuvant and adjuvant HER2+ early breast cancer UGN-103 delivers 94.5% six‑month durability in Phase 3 UTOPIA trial, with NDA submission planned for Q3 2026 to advance next‑generation RTGel therapy in recurrent LG‑IR‑NMIBC In Ph3 trial, Regeneron’s fianlimab + cemiplimab showed numeric PFS gain but missed statistical significance vs pembrolizumab in advanced or metastatic Melanoma CAN‑24

14/05/2026 Alembic secures USFDA tentative nod for Darolutamide tablets, 300 mg In Ph3 VOLGA trial, durvalumab + enfortumab vedotin significantly improved EFS and OS in MIBC Celcuity expands Phase 3 VIKTORIA-2 trial to include endocrine‑sensitive HR+/HER2‑ breast cancer patients Astellas files sNDA in Japan for PADCEV + Keytruda in cisplatin‑eligible muscle‑invasive bladder cancer, backed by Phase 3 EV‑304 survival benefit Alembic secures USFDA tentative nod for Darolutamide

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

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