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

09/03/2026 Johnson & Johnson's AKEEGA regimen received EC approval for the treatment of BRCA1/2-mutated mHSPC BMS announced positive Ph3 data of oral mezigdomide regimen in R/R Multiple Myeloma AstraZeneca and Daiichi Sankyo’s Enhertu received priority review status for HER2-positive early breast cancer Roche announced failure of the Phase 3 persevERA Breast Cancer trial Johnson & Johnson's AKEEGA regimen received EC approval for the treatment of BRCA1/2-mutated mHSPC ( Ref

18/02/2026 ImmunityBio's ANKTIVA® + BCG received conditional marketing authorization in Europe for BCG-unresponsive NMIBC CIS Johnson & Johnson's subcutaneous amivantamab received the FDA Breakthrough Therapy Designation for HPV-unrelated R/M SCCHN ImmunityBio's ANKTIVA® + BCG received conditional marketing authorization in Europe for BCG-unresponsive NMIBC CIS ( Ref ) The EC granted conditional marketing authorization to ImmunityBio's ANKTIVA® (nogapendekin alfa inbakicept)

09/02/2026 Krystal Biotech's KB707 received the FDA RMAT Designation for advanced or metastatic NSCLC Krystal Biotech's KB707 received the FDA RMAT Designation for advanced or metastatic NSCLC ( Ref ) The US FDA granted the Regenerative Medicine Advanced Therapy (RMAT) designation to Krystal Biotec's KB707 (redosable immunotherapy designed to drive sustained, localized expression of interleukin-2 and interleukin-12 in the tumor microenvironment) for the treatment of advanced

06/02/2026 The FDA approved a label update for Yescarta for Relapsed/Refractory Primary Central Nervous System Lymphoma The FDA approved a label update for Yescarta for Relapsed/Refractory Primary Central Nervous System Lymphoma ( Ref ) The US FDA approved an update to Gilead's Yescarta® (axicabtagene ciloleucel; anti-CD19 CAR T-cell therapy) prescribing information removing the previous Limitations of Use in patients with relapsed or refractory (R/R) primary central nervous

05/02/2026 Partner Therapeutics' zenocutuzumab received the FDA orphan drug designation for cholangiocarcinoma Partner Therapeutics' zenocutuzumab received the FDA orphan drug designation for cholangiocarcinoma ( Ref ) The US FDA granted the orphan drug designation to Partner Therapeutics' zenocutuzumab‑zbco (HER2xHER3 bispecific antibody) for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma. Zenocutuzumab is being developed in a subset of

03/02/2026 Relay Therapeutics' zovegalisib + fulvestrant received the FDA breakthrough therapy designation for breast cancer The US FDA granted priority review status to Datroway for the treatment of TNBC Relay Therapeutics' zovegalisib + fulvestrant received the FDA breakthrough therapy designation for breast cancer ( Ref ) The US FDA granted the breakthrough therapy designation to Relay Therapeutics' zovegalisib (PI3Kα inhibitor) + fulvestrant for the treatment of adults wi

02/02/2026 OS Therapies initiated US FDA BLA filing for OST-HER2 for Osteosarcoma Exelixis' NDA for zanzalintinib + atezolizumab in mCRC has been accepted for review by the US FDA TuHURA Biosciences' IFx-2.0 received the FDA orphan drug designation for cutaneous Melanoma OS Therapies initiated US FDA BLA filing for OST-HER2 for Osteosarcoma ( Ref ) OS Therapies has initiated a BLA submission to the US FDA for OST-HER2 (HER2-bioengineered form of Listeria monocytogenes) in the

29/01/2026 Quetzal Therapeutics' QTX-2101 received the FDA Fast Track designation for acute promyelocytic leukemia Summit's BLA for ivonescimab + chemo accepted by the FDA for EGFRm NSCLC The Phase III IMpower030 trial of perioperative atezolizumab + chemo failed to meet EFS endpoint in NSCLC Quetzal Therapeutics' QTX-2101 received the FDA Fast Track designation for acute promyelocytic leukemia ( Ref ) The US FDA granted the Fast Track designation to Quetzal Therapeutics' QTX

27/01/2026 Johnson & Johnson's DARZALEX FASPRO regimen has been approved in the US for multiple myeloma Imviva Biotech's CTD402 CAR-T received the FDA orphan drug designation for T-ALL/LBL Nanjing Leads Biolabs' LBL-034 received the FDA fast track designation for multiple myeloma Johnson & Johnson's DARZALEX FASPRO regimen has been approved in the US for multiple myeloma ( Ref ) The US FDA granted approval to Johnson & Johnson's DARZALEX FASPRO (daratumumab and hyaluronidase-

26/01/2026 Cogent Biosciences' bezuclastinib + sunitinib received the FDA Breakthrough Therapy Designation for GIST Innovent Biologics' IBI3003 received the FDA Fast Track Designation for multiple myeloma Cogent Biosciences' bezuclastinib + sunitinib received the FDA Breakthrough Therapy Designation for GIST ( Ref ) The US FDA granted the Breakthrough Therapy Designation to Cogent Biosciences' bezuclastinib (tyrosine kinase inhibitor) in combination with sunitinib for patien