27/08/2026 US FDA granted Fast track designation for Varseta-M in R/R Colorectal Cancer FDA clears path for Phase III melanoma trial of ruxotemitide + pembrolizumab US FDA granted Fast track designation for Varseta-M in R/R Colorectal Cancer (Ref) CytomX Therapeutics announced that the US FDA has granted Fast Track designation to Varsetatug masetecan (Varseta-M; EpCAM targeting ADC) for patients with relapsed/refractory metastatic colorectal cancer (R/R mCRC), based on encour

26/08/2026 US FDA Fast Track designation granted for SOT106 in Soft Tissue Sarcoma; First-in-Human Trial Planned in late-2026 US FDA Fast Track designation granted for SYS6090 in MSS/pMMR metastatic colorectal cancer Celcuity submits sNDA to US FDA for approval of gedatolisib combination therapy in PIK3CA-mutant HR+/HER2- advanced breast cancer US FDA Fast Track designation granted for SOT106 in Soft Tissue Sarcoma; First-in-Human Trial Planned in late-2026 (Ref) The US FDA h

25/08/2026 US FDA approves zanidatamab combination therapy in HER2+ GEA US FDA approves zanidatamab combination therapy in HER2+ GEA (Ref) The US FDA has approved Jazz, BeOne and Zymeworks' Ziihera (zanidatamab-hrii; bispecific HER2-directed antibody) with and without BeOne's tislelizumab (anti-PD-1) + chemotherapy for first-line treatment of HER2+ advanced gastroesophageal adenocarcinoma (GEA), regardless of PD-L1 status Approval was supported by Phase 3 HERIZON-GEA-01 trial

24/08/2026 EC Expands Trodelvy + Keytruda Approval to First-Line Metastatic TNBC Across PD-L1 Status US FDA accepts Jemperli for priority review in dMMR/MSI-H rectal cancer US FDA Fast Track designation granted for ERAS-0015 in metastatic pancreatic cancer; Phase 3 trial planned EC Expands Trodelvy + Keytruda Approval to First-Line Metastatic TNBC Across PD-L1 Status (Ref) European Commission’s expanded approval of Gilead’s Trodelvy (sacituzumab govitecan-hziy; Trop-2–directe

20/08/2026 US FDA Grants Fast Track Designation to Safusidenib for IDH1‑Mutant Glioma US FDA Grants Fast Track Designation to Safusidenib for IDH1‑Mutant Glioma (Ref) Nuvation Bio announced that the US FDA has granted Fast Track Designation to safusidenib (IDH1 inhibitor) for the treatment of IDH1‑mutant glioma. This designation enables expedited regulatory review and closer FDA engagement Phase 2 J201 trial showed a confirmed objective response rate of 51.9%, with durable re

19/08/2026 Phase 3 INTerpath-001 trial shows individualized mRNA therapy + KEYTRUDA improves survival in resected melanoma Phase 3 INTerpath-001 trial shows individualized mRNA therapy + KEYTRUDA improves survival in resected melanoma (Ref) Merck and Moderna announced that the Phase 3 INTerpath-001 trial evaluating intismeran autogene (V940/mRNA-4157), an individualized mRNA-based neoantigen therapy, in combination with KEYTRUDA® (pembrolizumab. anti-PD-1), achieved its prima

18/08/2026 BH-30643 earns US FDA Fast Track designation for pretreated NSCLC FDA Endorses Registrational Path for Pelareorep in RAS‑Mutant MSS Colorectal Cancer PLN-101095 Secures US FDA Fast Track for ICI-Refractory Solid Tumors US FDA Grants Fast Track to ETX‑19477, a Novel PARG Inhibitor for BRCA‑Mutated Breast Cancer BH-30643 earns US FDA Fast Track designation for pretreated NSCLC (Ref) BlossomHill Therapeutics announced that its investigational drug BH-30643, a macrocyc

17/08/2026 Enhertu delivers first-ever PFS benefit in 1L HER2-mutant NSCLC AstraZeneca halts Phase 3 eVOLVE-Lung02 trial of volrustomig in mNSCLC ORPATHYS + TAGRISSO deliver survival benefit in MET-driven EGFRm NSCLC US FDA fast track designation granted for PIKTOR + paclitaxel in biomarker-selected advanced Endometrial Cancer UroGen submits NDA for UGN-103 in recurrent LG-IR-NMIBC Enhertu delivers first-ever PFS benefit in 1L HER2-mutant NSCLC (Ref) AstraZeneca and Daiichi S

13/08/2026 US FDA Grants Type C Meeting to Review OST-HER2 Survival Data in Osteosarcoma Celltrion announced that CT-P73, tissue factor–targeting ADC for recurrent/metastatic cervical cancer, received FDA fast track designation US FDA Grants Type C Meeting to Review OST-HER2 Survival Data in Osteosarcoma (Ref) OS Therapies announced that the US FDA has granted a Type C Statistical Methods meeting to review 2.5-year overall survival data from the Phase 2b OST-HER2 trial in pul

12/08/2026 NMPA approves ivonescimab + chemo for first‑line advanced squamous NSCLC Zipalertinib Combo Achieves PFS Milestone in EGFR Exon 20 NSCLC, FDA Filing Planned NMPA approves ivonescimab + chemo for first‑line advanced squamous NSCLC (Ref) China’s NMPA approved Akeso Bio & Summit Therapeutics' ivonescimab (PD-1 x VEGF) in combination with chemotherapy as first-line treatment for advanced squamous non-small cell lung cancer (sq-NSCLC) The approval was based on the signi

09/08/2026 US FDA Fast Track Designation for FAP‑targeted radionuclide conjugate GPN01530-2 US FDA Fast Track Designation for FAP‑targeted radionuclide conjugate GPN01530-2 (Ref) Grand Pharmaceutical Group Limited announced that its investigational radionuclide-drug conjugate GPN01530-2, targeting fibroblast activating protein (FAP), has received Fast Track Designation from the US FDA

07/08/2026 BioInvent Secures US FDA Fast Track Designation for BI‑1808 in Ovarian Cancer BioInvent Secures US FDA Fast Track Designation for BI‑1808 in Ovarian Cancer (Ref) BioInvent has received US FDA Fast Track designation for BI‑1808, its first‑in‑class anti‑TNFR2 antibody, in combination with pembrolizumab for the treatment of ovarian cancer Supporting Phase 2a study results: 24.0% confirmed overall response rate (ORR) 56.0% disease control rate (DCR) Median progression‑

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