06/08/2026 US FDA Grants Accelerated Approval for Replimune’s TUDRIQEV + Nivolumab in Advanced Melanoma US FDA Grants Accelerated Approval for Replimune’s TUDRIQEV + Nivolumab in Advanced Melanoma (Ref) Replimune announced that the US FDA has granted accelerated approval for TUDRIQEV™ (vusolimogene oderparepvec-wtpg, formerly RP1; type 1 (HSV-1) oncolytic viral therapy) in combination with nivolumab for patients with unresectable advanced cutaneous Melanoma who have progresse

03/08/2026 US FDA grants Breakthrough Therapy designation to Lilly’s olomorasib for KRAS G12C-mutant pancreatic cancer FDA Grants Orphan Drug Designation to DLL3-Targeting ADC Zoci, for Neuroendocrine Carcinomas US FDA grants Breakthrough Therapy designation to Lilly’s olomorasib for KRAS G12C-mutant pancreatic cancer (Ref) Eli Lilly announced that the US FDA has granted Breakthrough Therapy designation to olomorasib (KRAS G12C inhibitor) as monotherapy for KRAS G12C-mutant a

02/08/2026 AstraZeneca and Bristol Myers Squibb Explore $400B Mega-Merger AstraZeneca and Bristol Myers Squibb Explore $400B Mega-Merger (Ref) AstraZeneca and Bristol Myers Squibb are engaged in discussions over a potential $400 billion merger, which would rank among the largest corporate deals in history Strategic Context: Bristol Myers has pursued aggressive acquisitions in the past, notably Medarex, which expanded its oncology pipeline AstraZeneca’s valuation has surged un

01/08/2026 Dr. Reddy’s secures US FDA approval for rituximab biosimilar, expanding its global oncology portfolio with Fresenius Kabi as exclusive US partner Dr. Reddy’s secures US FDA approval for rituximab biosimilar, expanding its global oncology portfolio with Fresenius Kabi as exclusive US partner (Ref) Dr. Reddy’s Laboratories received US FDA approval for its rituximab biosimilar (reference product: Rituxan®), a chimeric monoclonal antibody targeted against the pan-B-cel

31/07/2026 FDA grants tentative approval for OMCAZIO, a lower-dose Cabozantinib formulation with improved absorption Annamycin shows 37% CRc in Venetoclax-failed AML patients, with unblinded arms reaching up to 57% FDA grants tentative approval for OMCAZIO, a lower-dose Cabozantinib formulation with improved absorption (Ref) Handa Oncology announced that the US FDA has granted tentative approval for OMCAZIO (cabozantinib; multikinase inhibitor) capsules, a novel alternate-sal

30/07/2026 NMPA grants priority review to sacituzumab tirumotecan for first‑line TNBC FDA Advisory Committee Backs RP1's Efficacy Data in Advanced Melanoma FDA Grants Orphan Drug Designation to Enzomenib for Acute Lymphoblastic Leukemia REVTORPYK (gedatolisib) Added to NCCN Guidelines for HR+/HER2- Breast Cancer Karyopharm to file sNDA in Aug 2026, for selinexor + ruxolitinib in Myelofibrosis under accelerated approval pathway Selinexor Phase 3 Endometrial cancer trial shows

29/07/2026 The US FDA Grants RMAT & Fast Track to Allogene’s Cema‑cel for first‑Line LBCL consolidation The US FDA Grants RMAT & Fast Track to Allogene’s Cema‑cel for first‑Line LBCL consolidation (Ref) RMAT & Fast Track status granted to cemacabtagene ansegedleucel (cema‑cel; CAR T‑cell therapy) for the treatment of adult patients with large B-cell lymphoma (LBCL) who, at the completion of first-line therapy, are in complete or partial response suitable for observation but t

28/07/2026 Ris‑Rez achieves landmark Phase III PFS benefit in relapsed osteosarcoma FDA clears path for registrational Phase 2 of CLN-049 in AML Insilico Medicine's ISM6331 Earns US FDA Fast Track Designation for Advanced Mesothelioma Ris‑Rez achieves landmark Phase III PFS benefit in relapsed osteosarcoma (Ref) GSK's licensing partner Hansoh Pharma reported that its ARTEMIS-011 phase III trial of risvutatug rezetecan (Ris-Rez; B7-H3-targeted ADC) met the primary endpoint of

27/07/2026 Sone‑Ve delivers statistically significant OS benefit in CLDN18.2‑positive gastric/GEJ cancers, while PFS endpoint was not met Philogen resubmits EMA application for Nidlegy with extended Phase III data CG Oncology Publishes Pivotal Phase 3 BOND-003 Cohort C Results in The Lancet Oncology Sone‑Ve delivers statistically significant OS benefit in CLDN18.2‑positive gastric/GEJ cancers, while PFS endpoint was not met (Ref) AstraZeneca's Phase 3 CLARITY-Gastric01 trial

23/07/2026 Phase 3 MonumenTAL-6 study shows PFS benefit for TECVAYLI + TALVEY combo in Multiple Myeloma Epcoritamab Phase 3 DLBCL trial failed to meet OS endpoint Phase 3 MonumenTAL-6 study shows PFS benefit for TECVAYLI + TALVEY combo in Multiple Myeloma (Ref) Johnson & Johnson announced positive topline results from the Phase 3 MonumenTAL-6 trial of TECVAYLI and TALVEY combinations in relapsed/refractory multiple myeloma patients. MonumenTAL-6 trial evaluated TECVAYLI® (tec

22/07/2026 Ivonescimab plus chemotherapy delivers consistent overall survival gains across Western and Asian NSCLC patients, reinforcing FDA‑filed Phase III HARMONi data US FDA grants Priority Review for talazoparib + enzalutamide in HRR‑mutated mCSPC, with a decision expected in Q4 2026 US FDA Accepts NDA for Daraxonrasib in Previously Treated Metastatic Pancreatic Cancer GSK's Jideytro (zidesamtinib) Gets US FDA Approval for ROS1-Positive Lung Cancer Ivonescimab plus chemot

21/07/2026 Toripalimab + chemo gains NMPA acceptance as perioperative NSCLC therapy, cutting recurrence risk by 60% Toripalimab + chemo gains NMPA acceptance as perioperative NSCLC therapy, cutting recurrence risk by 60% (Ref) The National Medical Products Administration (NMPA) has accepted Junshi Biosciences’ supplemental application for toripalimab + platinum chemotherapy as perioperative treatment (plus adjuvant monotherapy) for resectable stage II–III NSCLC patients The s

20/07/2026 US FDA Fast Track Designation Secured for Pelareorep in Advanced Anal Cancer US FDA Grants Tentative Approval for NATCO’s Generic Olaparib US FDA Fast Track Designation Secured for Pelareorep in Advanced Anal Cancer (Ref) Oncolytics Biotech's Pelareorep (double-stranded RNA immunotherapy), in combination with a checkpoint inhibitor, received Fast Track designation for second-line and later squamous cell carcinoma of the anal canal (SCAC) patients who progressed aft

17/07/2026 China NMPA grants approval to iza‑bren, delivering survival benefit in recurrent/metastatic ESCC after PD‑1/PD‑L1 therapy China NMPA grants approval to iza‑bren, delivering survival benefit in recurrent/metastatic ESCC after PD‑1/PD‑L1 therapy (Ref) China’s NMPA approved Biokin Pharma's iza-bren (izalontamab brengitecan; EGFR x HER3 bispecific ADC) for recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after progression on platinum-based chemotherapy

July 2nd Week, 2026 Special Designation ⭐ PRG S&Tech Inc.’s Trineumin (small-molecule modulator of the abnormal TβR1-RKIP interaction (caused by NF2 gene mutation)) has been granted the Rare Pediatric Disease Designation (RPDD) by the US FDA for the Tx of Neurofibromatosis Type 2 (NF2) (Ref) ❓ What is the addressable market for NF2 in the US? ⭐ CSPC Pharmaceutical Group's SYS6043 (B7-H3 ADC) received the Breakthrough Therapy Designation from China’s NMPA for the Tx of plati

15/07/2026 Sacituzumab tirumotecan (sac-TMT) + pembrolizumab improved PFS vs chemo + pembrolizumab in PD-L1–negative NSCLC KEYTRUDA delivers first-ever PFS benefit over chemotherapy in frontline dMMR endometrial cancer Sacituzumab tirumotecan (sac-TMT) + pembrolizumab improved PFS vs chemo + pembrolizumab in PD-L1–negative NSCLC (Ref) Sichuan Kelun-Biotech announced positive Phase 3 OptiTROP-Lung06 trial results for its TROP2 ADC sacituzumab tirumotecan (sac-TMT, SKB264/MK-28

14/07/2026 FDA frants Fast Track Designation to SOTIO’s SOT109 (CDH17-targeting) ADC for advanced Colorectal Cancer FDA grants full approval to selpercatinib for RET fusion positive solid tumors AstraZeneca secures global rights to Zegfrovy, first oral EGFR exon 20 NSCLC therapy, in $600M upfront deal with Dizal In a Ph3 trial, HBI-8000 + nivolumab improved PFS vs nivolumab + placebo, for advanced Melanoma FDA approved first generics of Gilotrif (afatinib) for EGFR‑mutant and

13/07/2026 FDA accepts BMS’s NDA for mezigdomide in relapsed/refractory Multiple Myeloma GSK’s dostarlimab (aPD-1) delivers sustained complete responses in dMMR/MSI-H rectal cancer FDA accepts BMS’s NDA for mezigdomide in relapsed/refractory Multiple Myeloma (Ref) The US FDA has accepted Bristol Myers Squibb’s New Drug Application (NDA) for mezigdomide in combination with carfilzomib and dexamethasone (MeziKd) for relapsed/refractory multiple myeloma (RRMM) A Prescription Dru

10/07/2026 FDA rejects Elevar’s rivoceranib + camrelizumab HCC NDA due to manufacturing compliance Risvutatug Rezetecan delivered first Phase III overall survival benefit vs topotecan, in relapsed small cell lung cancer FDA rejects Elevar’s rivoceranib + camrelizumab HCC NDA due to manufacturing compliance (Ref) Elevar Therapeutics announced on that the FDA declined to approve its combination therapy of rivoceranib (VEGFR TKI) and camrelizumab (anti–PD-1) as a first-line trea

09/07/2026 CSPC’s B7-H3 ADC SYS6043 secures Breakthrough Therapy Designation in China for platinum-resistant Ovarian cancer CSPC’s B7-H3 ADC SYS6043 secures Breakthrough Therapy Designation in China for platinum-resistant Ovarian cancer (Ref) CSPC Pharmaceutical's antibody-drug conjugate (ADC) SYS6043, targeting B7-H3, has received Breakthrough Therapy Designation from China’s NMPA for platinum-resistant ovarian cancer, primary peritoneal carcinoma, and fallopian tube cancer