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

BGB-16673 Receives US FDA Fast Track Designation for CLL/SLL

September 3, 2024

FDA accepts sBLA for 1L HCC based on Ph 3 CheckMate -9DW trial demonstrating improved survival with Opdivo + Yervoy vs SoC; PDUFA: Apr 2025

August 27, 2024

FDA issues a CRL for linvoseltamab’s BLA in R/R multiple myeloma that has progressed after at least three prior therapies

August 27, 2024

FDA grants Breakthrough Therapy Designation to GSK5764227 for R/R extensive-stage SCLC

August 27, 2024

TROP2-ADC SKB264 (sac-TMT) Second NDA Accepted by NPMA for locally advanced or metastatic EGFR-mutant NSCLC

August 27, 2024

Human Research Ethics Committee (HREC) in Australia clears initiation of Ph 1 trial of MNPR-101-Lu

August 27, 2024

FDA clears IND application for Ph 1/2 ATALANTA-1 study of GLPG5101 in R/R NHL

August 27, 2024

FDA granted Fast Track Designation to APG-157 for the neoadjuvant treatment of Head and Neck Cancer (HNC)

August 27, 2024

Imfinzi granted Priority Review and Breakthrough Therapy Designation for patients with limited-stage SCLC in the US

August 22, 2024

ENHERTU® Granted Breakthrough Therapy Designation in U.S. for Certain Patients with HER2 Low or HER2 Ultralow Metastatic Breast Cancer

August 22, 2024

FDA Clears IND Application for Ph 1b Study of PTM-101 for the Localized Treatment of Pancreatic Cancer

August 22, 2024

BRG01 Receives FDA Approval for Ph 2 Trial for the treatment of relapsed/metastatic EBV-positive NPC

August 22, 2024

ENHERTU Type II Variation Application Validated by EMA for Patients with HER2 Low or Ultralow Metastatic Breast Cancer Following At Least One Endocrine Therapy

August 22, 2024

FDA Meeting on Ph 2 Study of Leronlimab in Patients with R/R MSS CRC completed

August 22, 2024

NDA submission for UGN-102 for Low-Grade Intermediate-Risk NMIBC completed

August 22, 2024

FDA granted Fast Track designation to Deltacel™ (KB-GDT-01) Gamma Delta T-cell (GDT) therapy

August 22, 2024

FDA Fast Track Designation for AC699 in ER+ / HER2- Breast Cancer

August 22, 2024

Successful End-of-Phase 2 Meeting with FDA for Amezalpat (TPST-1120) to Treat 1L HCC Announced

August 22, 2024

Ph 3 SIERRA trial deemed inadequate to support BLA filing for Iomab-B; additional head-to-head RCT demonstrating OS benefit required

August 22, 2024

PT217 receives Orphan Drug Designation for Neuroendocrine Carcinoma from the FDA

August 21, 2024

FDA grants Fast Track Designation for HP518 for Treatment of AR+ TNBC

August 13, 2024

FDA Clears IND Application for Ziftomenib in Advanced Gastrointestinal Stromal Tumors (GIST)

August 13, 2024

FDA provides IND requirements for the development of ALA-101 in first-inhuman clinical trials for lymphoma and leukaemia

August 13, 2024

EMA grants Approval to Initiate Ph 1 Clinical Trial of JK06

August 13, 2024

FDA accepts sNDA for Cabozantinib for Patients with Advanced Neuroendocrine Tumors

August 13, 2024
Page1 … Page10 Page11 Page12 Page13 Page14 … 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.