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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

FDA Fast Track Designation for ALE.P02 for the Treatment of CLDN1+ Squamous Solid Tumors

November 19, 2024

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

November 19, 2024

Datopotamab deruxtecan new BLA submitted for accelerated approval in the US for patients with previously treated advanced EGFR-mutated NSCLC

November 19, 2024

FDA Rare Pediatric Disease Designation Granted to Elraglusib for Treatment of Ewing Sarcoma

November 19, 2024

FDA Study May Proceed Letter received for Pivotal Ph 3 Trial of Amezalpat Combination Therapy for the Treatment of 1L HCC

November 19, 2024

Institutional Review Board Approves MIRACLE Ph 3 Pivotal Trial of Annamycin in Combination with Cytarabine for the Treatment of R/R AML

November 19, 2024

FDA clears IND Application to Initiate Ph 1 Clinical Trial of CER-1236 in AML

November 19, 2024

Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) + Chemo as 1L Treatment for Adult Patients With Unresectable Non-Epithelioid MPM

November 19, 2024

CHMP recommends RYBREVANT® (amivantamab) + LAZCLUZE® (lazertinib) for 1L treatment of patients with EGFR-mutated advanced NSCLC

November 19, 2024

Positive CHMP Opinion for Opdivo® (nivolumab) + Yervoy® (ipilimumab) for the First-Line Treatment of Adult Patients with MSI-H or MRD Metastatic CRC

November 19, 2024

Tagrisso recommended for approval in the EU by CHMP for patients with unresectable EGFR-mutated lung cancer based on Ph 3 LAURA trial results

November 19, 2024

FDA gives clearance to commence Ph 2 trial of leronlimab in patients with R/R MSS CRC

November 13, 2024

Type C Meeting granted with FDA to Discuss Potential Next Steps for Paxalisib in the Treatment of Newly Diagnosed GBM

November 13, 2024

FDA extends PDUFA for zenocutuzumab

November 13, 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.