15/10/2026 US FDA grants second Fast Track Designation to Invikafusp Alfa in checkpoint-refractory TMB-High solid tumors Revolution Medicines' RASONQUE receives positive CHMP opinion for Metastatic Pancreatic Cancer US FDA grants second Fast Track Designation to Invikafusp Alfa in checkpoint-refractory TMB-High solid tumors (Ref) Marengo Therapeutics announced that the US FDA has granted a second Fast Track Designation (FTD) to Invikafusp alfa (STAR0602; bispecific dual T-cel

12/10/2026 Opamtistomig (PD-L1 x 4-1BB BsAb) receives US FDA Fast Track Designation in First-Line Biliary Tract Cancer In Phase 3 ACTION-1 trial, RYZ101 met primary endpoint of PFS in patients with GEP-NETs HLB/Elevar Resubmits US FDA application for first-line Liver Cancer combination US FDA grants Fast Track Designation to AST-301 for HER2-Positive Gastric Cancer Opamtistomig (PD-L1 x 4-1BB BsAb) receives US FDA Fast Track Designation in First-Line Biliary Tract Cancer (Ref

08/10/2026 US FDA approved atezolizumab + chemotherapy for adjuvant treatment of stage III dMMR Colon Cancer Perspective therapeutics receives US FDA Fast Track Designation for [212Pb]PSV359 in Solitary Fibrous Tumors US FDA granted Fast Track Designation to VIR-5500 in mCRPC China NMPA approves Enhertu as adjuvant therapy for HER2-positive early breast cancer and Datroway for metastatic TNBC US FDA approved atezolizumab + chemotherapy for adjuvant treatment of stage III dMMR

21/09/2026 PureTech Secures FDA Alignment and Fast Track Designation for LYT-200 in Relapsed/Refractory High-Risk MDS PureTech Secures FDA Alignment and Fast Track Designation for LYT-200 in Relapsed/Refractory High-Risk MDS (Ref) PureTech announced a positive regulatory milestone for its investigational therapy, LYT-200 (anti-Gal-9), including successful FDA alignment on its development path and receipt of Fast Track Designation in relapsed/refractory high-risk myelodysplast

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

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

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

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

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

09/06/2026 Imugene’s Azer-cel secures FDA Fast Track for CLL/SLL and MZL FDA grants RedHill’s opaganib Rare Pediatric Disease designation for neuroblastoma Serplulimab secures world‑first approval as a chemo‑sparing perioperative immunotherapy for gastric cancer FDA grants RMAT to lasme‑cel, advancing the first off‑the‑shelf CAR‑T into pivotal r/r B‑ALL trial Imugene’s Azer-cel secures FDA Fast Track for CLL/SLL and MZL (Ref) Imugene's Azer-cel (azercabtagene zapreleucel; CD1

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

27/05/2026 FDA grants Fast Track to Solu’s STX‑0712 for relapsed/refractory CMML, advancing CyTAC™ platform into Phase 1 hematology trials FDA grants Fast Track to Solu’s STX‑0712 for relapsed/refractory CMML, advancing CyTAC™ platform into Phase 1 hematology trials (Ref) Solu Therapeutics’ investigational therapy STX-0712 has received Fast Track designation for relapsed/refractory chronic myelomonocytic leukemia (CMML) Ongoing Trials - A Phase 1, open-label, multicenter tria

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,

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

20/04/2026 Arcus halts Lung Cancer Trial With Gilead After Futility Analysis FDA granted Fast Track designation for Lunresertib + Zedoresertib in Platinum-Resistant Ovarian Cancer FDA Grants Orphan Drug Status to Orion’s ODM-212 for Mesothelioma FDA Grants Priority Review for PADCEV + Keytruda in Muscle-Invasive Bladder Cancer Arcus halts Lung Cancer Trial With Gilead After Futility Analysis (Ref) Arcus Biosciences has halted its Phase 3 lung cancer trial with Gilead Sciences

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.S.

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 Administ

07/04/2026 Corbus Gains FDA Alignment on CRB‑701 Registrational Trials in HNSCC and Cervical Cancer Nuvalent Submits NDA for Neladalkib in ALK+ NSCLC NextCure Receives Fast Track Designation for SIM0505 (CDH6 ADC) in Ovarian Cancer Corbus Gains FDA Alignment on CRB‑701 Registrational Trials in HNSCC and Cervical Cancer (Ref) Corbus reached broad agreement with the FDA on the registration path for CRB-701, a next-generation Nectin-4 targeting antibody-drug conjugate (ADC), in

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