Skip to content
Linkedin
RLS logo_header
  • Drug Approvals
  • Regulatory News
  • Trial Results
  • Trial Status
  • Business News
  • Conference Coverage
  • About Us
  • Drug Approvals
  • Regulatory News
  • Trial Results
  • Trial Status
  • Business News
  • Conference Coverage
  • About Us
  • Choose Speciality

    Post content

    • Brain Cancer
    • Breast Cancer
      • HER2+ HRneg Breast Cancer
      • HR+ HER2neg Breast Cancer
      • TNBC
    • GI Cancers
      • Cholangiocarcinoma
      • Colorectal Cancer
      • Esophageal Cancer
      • Gastric Cancer
      • GEJ
      • GIST
      • HCC
      • Pancreatic Cancer
    • GU Cancers
      • Bladder Cancer
      • Prostate Cancer
      • Renal Cell Carcinoma
    • Gynecological Cancers
      • Cervical Cancer
      • Endometrial Cancer
      • Ovarian Cancer
    • Head & Neck Cancer
      • Nasopharyngeal Carcinoma
      • Oropharyngeal Cancer
    • Hematological Malignancies
      • CAR-Ts
    • Leukemias
      • ALL
      • AML
      • Chronic Myeloid Leukemia
      • CLL/SLL
      • CMML
    • Lung Cancer
      • Biomarker-Driven Lung Cancer
      • EGFR+ Lung Cancer
      • Non-Small Cell Lung Cancer
      • Small Cell Lung Cancer
    • Lymphomas
      • DLBCL
      • Follicular Lymphoma
      • Hodgkin’s Lymphoma
      • Mantle Cell Lymphoma
      • Non-Hodgkin’s Lymphoma
      • T-Cell Lymphoma
    • MPNs
    • Multiple Myeloma
    • Myelodysplastic Syndromes
    • Neuroendocrine Tumors
    • Sarcoma
    • Skin Cancer
    • Solid Tumors
    • Thyroid Cancer
    • Uveal Melanoma
  • Drug Approvals
  • Regulatory News
  • Trial Results
  • Trial Status
  • Business News
  • Conference Coverage
  • About Us
  • Drug Approvals
  • Regulatory News
  • Trial Results
  • Trial Status
  • Business News
  • Conference Coverage
  • About Us
  • Choose Speciality

    Post content

    • Brain Cancer
    • Breast Cancer
      • HER2+ HRneg Breast Cancer
      • HR+ HER2neg Breast Cancer
      • TNBC
    • GI Cancers
      • Cholangiocarcinoma
      • Colorectal Cancer
      • Esophageal Cancer
      • Gastric Cancer
      • GEJ
      • GIST
      • HCC
      • Pancreatic Cancer
    • GU Cancers
      • Bladder Cancer
      • Prostate Cancer
      • Renal Cell Carcinoma
    • Gynecological Cancers
      • Cervical Cancer
      • Endometrial Cancer
      • Ovarian Cancer
    • Head & Neck Cancer
      • Nasopharyngeal Carcinoma
      • Oropharyngeal Cancer
    • Hematological Malignancies
      • CAR-Ts
    • Leukemias
      • ALL
      • AML
      • Chronic Myeloid Leukemia
      • CLL/SLL
      • CMML
    • Lung Cancer
      • Biomarker-Driven Lung Cancer
      • EGFR+ Lung Cancer
      • Non-Small Cell Lung Cancer
      • Small Cell Lung Cancer
    • Lymphomas
      • DLBCL
      • Follicular Lymphoma
      • Hodgkin’s Lymphoma
      • Mantle Cell Lymphoma
      • Non-Hodgkin’s Lymphoma
      • T-Cell Lymphoma
    • MPNs
    • Multiple Myeloma
    • Myelodysplastic Syndromes
    • Neuroendocrine Tumors
    • Sarcoma
    • Skin Cancer
    • Solid Tumors
    • Thyroid Cancer
    • Uveal Melanoma
Linkedin

FDA Orphan Drug Designation for PEP-010 for treatment of Pancreatic Cancer

March 18, 2025

Selective ATM Inhibitor SYH2051 Obtains Clinical Trial Approval in the U.S.

March 18, 2025

U.S. FDA Orphan Drug Designation Granted to Bexobrutideg (NX-5948) for the Treatment of Waldenström Macroglobulinemia

March 18, 2025

Olverembatinib Granted Breakthrough Therapy Designation for the Treatment of Philadelphia Chromosome-Positive (Ph+) ALL

March 11, 2025

FDA Clears IND Application for CD7 UCAR T Cell Therapy in T-ALL/LBL

March 11, 2025

FDA Grants Orphan Drug Designation for Bexmarilimab in MDS

March 11, 2025

FDA’s IND Approval of LAE120 for Treatment of Advanced Solid Tumors Announced

March 11, 2025

FDA accepts sBLA for Opdivo + Yervoy for Patients with Unresectable or Metastatic MSI-H or MRD CRC

March 4, 2025

FDA clears IND application for LTZ-301 to treat R/R NHL

March 4, 2025

FDA Fast Track Designation for PYX-201 Monotherapy in Patients with Recurrent or Metastatic Head and Neck Cancer

March 4, 2025

FDA Grants Priority Review to KEYTRUDA + SOC as Perioperative Treatment for Resectable Locally Advanced SCCHN; PDUFA: Jun 23, 2025

March 4, 2025

Odronextamab BLA Accepted for FDA Review for the Treatment of R/R Follicular Lymphoma

March 4, 2025

FDA RMAT Designation for CAR-NK in Multiply Relapsed Locally Advanced or Metastatic Pancreatic Cancer

March 4, 2025

FDA approves IND Application for Ph 1 Tiffany-01 Trial of ADCE-T02 in solid tumors

March 4, 2025

FDA Approves IND for FP008 for Solid Tumors

March 4, 2025

CHMP recommends EU approval of Columvi combination for people with R/R DLBCL

March 4, 2025

Imfinzi-based perioperative regimen recommended for approval in the EU by CHMP for resectable NSCLC

March 4, 2025

Enhertu recommended for approval in the EU by CHMP for patients with HER2-low or HER2-ultralow metastatic breast cancer following at least one endocrine therapy

March 4, 2025

Linvoseltamab Recommended for EU Approval by the CHMP to Treat R/R Multiple Myeloma

March 4, 2025

DARZALEX® (daratumumab) SC-based regimen receives positive CHMP opinion for patients with newly diagnosed multiple myeloma, regardless of transplant eligibility

March 4, 2025

Jaypirca (pirtobrutinib) recommended by CHMP for approval in the EU for adults with R/R CLL previously treated with a BTKi

March 4, 2025

Fast Track Designation from the US FDA for IBI363 in Squamous NSCLC

February 25, 2025

Zongertinib receives Priority Review from US FDA for the treatment of HER2-mutant advanced NSCLC

February 25, 2025

RZ-001 Gains Fast Track Status for HCC, Following GBM

February 25, 2025

AUTX-703 Granted Fast Track Designation by the FDA for R/R AML

February 25, 2025
Page1 Page2 Page3 Page4 Page5 … Page31

Onco-This-Week

  • Business News
  • Drug Approvals
  • Regulatory News
  • Trial Results
  • Trial Status
  • Conference Coverage

About Us

Sign up for OTW

Linkedin

Disclaimer: The OTW team takes care to share authentic information. In case of any discrepancies please write to newsletter@onco-this-week.com. Our website is an aggregator for open-source oncology news. The information on our website is provided without any representations or warranties. OTW is part of RLS Consultants, a global consulting and training firm focusing exclusively on the healthcare and life sciences industries. RLS is a leading provider of opportunity assessment services, utilizing its comprehensive expertise in strategic market research, forecasting, and modeling, as well as pricing and market access to facilitate commercial assessments. RLS does not have any influence on any news reported on OTW. The views and opinions expressed in this article are those of the authors and do not necessarily reflect the official policy or position of RLS. The content on our website is intended strictly for news and information purposes only and should not be treated as a substitute for medical advice, diagnosis, or treatment. News shared on OTW should not be utilized in real-world analytic products as they are based only on limited and dated open-source information.