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Linkedin

Positive CHMP Opinion for Epcoritamab (TEPKINLY®) for the Treatment of Adults with R/R Follicular Lymphoma

July 1, 2024

SC amivantamab BLA submitted to FDA for patients with EGFR-mutated NSCLC

June 25, 2024

EMA validates extension application for SC formulation for Opdivo including liquid formulation and new strength across previously approved indications 

June 25, 2024

China’s NMPA approves IND for GFH375 for Ph 1/2 Clinical Trial Treating Advanced Solid Tumor Patients with KRAS G12D Mutation

June 25, 2024

Fast Track Designation from the U.S. FDA for IBI343 (TOPO1i anti-CLDN18.2 ADC) as Monotherapy for Advanced Pancreatic Cancer

June 18, 2024

Orphan Drug Designation Granted by the U.S. FDA for SL-172154 for the Treatment of AML

June 18, 2024

Tagrisso granted Priority Review in the US for patients with unresectable, Stage III EGFR-mutated lung cancer

June 18, 2024

European Commission granted Orphan Drug Designation to UCART22 for the treatment of ALL

June 11, 2024

Fast Track Designation Granted by the FDA for Lunresertib in Combination with Camonsertib for the Treatment of Platinum-Resistant Ovarian Cancer

June 11, 2024

FDA clears IND for Ph 1/2a trial (TCX-101) of BSB-1001 for patients with R/R AML, ALL and MDS, in conjunction with alloHSCT

June 11, 2024

IND Filing for PFL-002/VERT-002 for Patients with Solid Tumors Including NSCLC with MET Alterations

June 11, 2024

FDA Approved Ph 2/3 Study of KPG-121 in Combination with Abiraterone as a 1L Treatment for mCRPC

June 11, 2024

Ph 3 pivotal Namodenoson HCC study recruiting in medical centers in Europe, Israel and the US

June 11, 2024

EMA CHMP Recommends Approval of Cejemly® (sugemalimab) as 1L Treatment for NSCLC

June 4, 2024

FDA approves zolbetuximab BLA resubmission for 1L locally advanced unresectable or metastatic CLDN18.2+ve HER2-neg gastric or GEJ adenocarcinoma; new PDUFA: Nov 9, 2024

June 4, 2024

FDA Grants Orphan Drug Designation for CAN-3110 for the Treatment of Recurrent High-Grade Glioma

June 4, 2024

FDA clears IND Application for 225Ac-FL-020 for the Treatment of mCRPC

June 4, 2024

FDA grants RMAT designation to TSC-100 & TSC-101 for the treatment of patients with AML, ALL, and MDS undergoing allogeneic HCT with reduced intensity conditioning

June 4, 2024

FDA Clears IND Application for SYNC-T SV-102, a First-In-Class Combination Multi-Target Immunotherapy for mCRPC

June 4, 2024

IND application of ANV600-001 (EXPAND) Ph 1/2 clinical study approved

June 4, 2024

Ph 2/3 TEBE-AM trial converted into registrational Ph 3 trial of KIMMTRAK for previously treated advanced cutaneous melanoma

June 4, 2024

Sarclisa Accepted For FDA Priority Review For The Treatment Of Transplant-Ineligible Newly Diagnosed Multiple Myeloma

June 4, 2024

FDA grants Fast Track Designation for Combination Therapy of AFM24 with Atezolizumab for EGFR WT NSCLC

June 4, 2024

FDA grants Priority Review to inavolisib for advanced HR+ve, HER2-neg breast cancer with a PIK3CA mutation

June 4, 2024

FDA Grants Priority Review to sBLA for KEYTRUDA + Chemo as 1L Treatment of Patients With Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma

June 4, 2024
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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.