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Linkedin

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

FDA Updates Action Date for Subcutaneous Nivolumab (nivolumab and hyaluronidase); new PDUFA: December 29, 2024

May 29, 2024

FDA grants Breakthrough Therapy Designation to inavolisib for advanced HR-positive, HER2-negative breast cancer with a PIK3CA mutation

May 29, 2024

NMPA of China Accepted and Granted Priority Review Designation to the NDA for Glecirasib

May 29, 2024

FDA Grants Orphan Drug Designation to Azeliragon for Pancreatic Cancer

May 29, 2024

RMAT and PRIME Designations granted to WU-CART-007

May 29, 2024

Fast Track Designation Granted by the U.S. FDA for VCN-01 for the Treatment of Metastatic Pancreatic Cancer

May 29, 2024

Rolling Submission of NDA to FDA initiated for Seeking Accelerated Approval of Avutometinib and Defactinib Combination for the Treatment of Adult Patients with Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer

May 29, 2024

Petosemtamab granted Breakthrough Therapy Designation by the U.S. FDA

May 21, 2024

US FDA accepts Protocol for New Randomized Ph 2 Study of NBTXR3 for Patients with Stage 3 Lung Cancer

May 21, 2024

China CDE Clearance for Ph 3 Trial of KRAS G12C Inhibitor Glecirasib in Patients with CRC Announced

May 21, 2024

Paediatric Investigation Plan Waiver Received from the European Medicines Agency for Certepetide in Pancreatic Cancer

May 21, 2024

IND Clearance from the FDA for SynKIR™-310 in R/R B-cell NHL

May 21, 2024

FDA Grants Type B End-of-Phase 2 Meeting to Discuss BOT/BAL Therapy for R/R Metastatic CRC

May 21, 2024

U.S. FDA Breakthrough Therapy Designation for NVL-655

May 21, 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.