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FDA Granted Fast Track Designation for 225Ac-FL-020 for the Treatment of Metastatic CRPC

July 9, 2024

FDA clears IND Application for GTB-3650 for Treatment of CD33+ Leukemia

July 1, 2024

Patritumab Deruxtecan BLA Submission Receives CRL from FDA Due to Inspection Findings at Third-Party Manufacturer

July 1, 2024

FDA Clears IND Application for ADI-270 in RCC

July 1, 2024

FDA aligns on BLA resubmission strategy for cosibelimab

July 1, 2024

FDA Rare Pediatric Disease Designation Granted to SLS009 for the Treatment of Pediatric ALL

July 1, 2024

FDA Fast Track Designation for CT-0525 for the Treatment of HER2-overexpressing Solid Tumors

July 1, 2024

FDA grants Fast Track Designation for ABD-147 for the Treatment of Patients with Extensive-stage SCLC

July 1, 2024

FDA grants Fast Track Designation for TUB-040 in Platinum-resistant Ovarian Cancer

July 1, 2024

EMA Approves MDNA11 CTA to Expand Ph 1/2 ABILITY-1 Study to Europe

July 1, 2024

Odronextamab Recommended for EU Approval by the CHMP to Treat R/R Follicular Lymphoma and DLBCL

July 1, 2024

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
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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.