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 Grants Fast Track Designation to CRB-701 for the Treatment of R/R Metastatic Cervical Cancer

December 10, 2024

FDA Grants Breakthrough Therapy Designation to Sacituzumab Tirumotecan (sac-TMT) for the Treatment of Certain Patients With Previously Treated Advanced or Metastatic Nonsquamous NSCLC With EGFR Mutations

December 10, 2024

FDA accepts sBLA for Columvi combination for people with R/R DLBCL

December 10, 2024

PT217 granted Fast Track Designation by the FDA for NEPC

December 10, 2024

FDA granted RMAT designation to acimtamig and AlloNK (AB101) for the treatment of R/R HL

December 10, 2024

Outcomes of Type D meeting with FDA to obtain guidance on the design of a Ph 3 study of VCN-01 + chemo in metastatic pancreatic adenocarcinoma (PDAC) announced

December 10, 2024

AdAPT-001 Receives FDA Fast Track Designation for Recurrent or Refractory Soft Tissue Sarcoma Treatment

December 10, 2024

FDA Orphan Drug Designation for Azeliragon for the Treatment of Brain Metastasis From Breast Cancer

December 10, 2024

FDA Clears Investigational New Drug Application for OP-3136

December 10, 2024

Imfinzi granted Priority Review in the US for patients with muscle-invasive bladder cancer

December 10, 2024

FDA Clears IND Application for AI-081 in Advanced Solid Tumors

December 9, 2024

FDA Fast Track Designation For LBS-007

December 4, 2024

Regulatory Update Related to sNDA for Cabozantinib (CABOMETYX) for the Treatment of Patients with Previously Treated Advanced NET Provided

December 4, 2024

R289 Granted Fast Track Designation by the FDA for Lower-Risk MDS

December 4, 2024

FDA Clears IND Application for Ph 2 Clinical Trial of HEPZATO™ in Liver-Dominant Metastatic CRC

December 4, 2024

IND clearance received from FDA for ISM5939 for solid tumors

December 4, 2024

CTA submitted to the EMA for a Ph 1/2 multi-asset umbrella trial, VIDAR-1

December 4, 2024

Results from End-of-Phase 2 Meeting with FDA for IMNN-001 Program in Advanced Ovarian Cancer Announced

November 26, 2024

FDA Accepts sNDA for NUBEQA® (darolutamide) for the Treatment of Patients with Metastatic Hormone-Sensitive Prostate Cancer

November 26, 2024

RZ-001 approved for sympathetic use (EAP) by the FDA

November 26, 2024

Breakthrough Therapy Designation for RP1 and RP1 BLA submitted to the FDA under the Accelerated Approval Pathway

November 26, 2024

FDA Granted Orphan Drug Designation of LBL-024 for Treatment of Neuroendocrine Cancer

November 26, 2024

NDA for Lisaftoclax Accepted and Recommended Priority Review Designation by CDE of China NMPA

November 26, 2024

Blenrep combinations accepted for review by the FDA for the treatment of R/R multiple myeloma

November 26, 2024

Positive CHMP Opinion for Repotrectinib for the Treatment of Advanced ROS1-Positive NSCLC and Advanced NTRK-Positive Solid Tumors

November 19, 2024
Page1 … Page5 Page6 Page7 Page8 Page9 … 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.