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Linkedin

CHMP recommends EU label update for Phesgo to allow administration outside of clinical settings

May 6, 2025

FDA clears IND application for LP-184 for Ph 1b/2 Trial in TNBC patients

May 6, 2025

FDA Fast Track Designation for INX-315 to Treat CCNE1-Amplified Platinum-Resistant/Refractory Ovarian Cancer

May 6, 2025

FDA Feedback Provided to Enable Direct Ph 2 Trial for Gengleucel in MRD+ AML

May 6, 2025

Zurletrectinib Receives Priority Review from China’s NMPA

May 6, 2025

sBLA submission to FDA for Epcoritamab + Rituximab and Lenalidomide (R2) in Patients with R/R Follicular Lymphoma planned

May 6, 2025

FDA clears IND application for Ph 1/2 Study of OBI-902 in solid tumors

May 6, 2025

FDA clears IND Application for NTS071 for Ph 1 trial

May 6, 2025

FDA Fast Track Designation for ISB 2001 for R/R Multiple Myeloma

May 6, 2025

FDA Fast Track Designation for BI-1808 to Treat Cutaneous T-cell Lymphoma

May 6, 2025

Fixed-duration Calquence-based regimens recommended for approval in the EU by CHMP for 1L CLL

May 6, 2025

CHMP Positive Opinion for Zanidatamab for the Treatment of Advanced HER2-Positive Biliary Tract Cancer

April 30, 2025

FDA clears IND application for VS-7375, Enabling Ph 1/2a Trial in Advanced Solid Tumors

April 30, 2025

EMA gives IMPD approval to initiate Ph 1 trial of OT-C001 + Rituximab in DLBCL patients

April 30, 2025

EMA granted orphan drug status to AB8939 for the treatment of AML

April 30, 2025

FDA Clears IND Application for Ph 2 Trial of TGW101 in advanced solid tumors

April 30, 2025

FDA clears IND application to Initiate Clinical Development of ETX-636

April 30, 2025

FDA Clears IND Application for Ph 2 Trial of HEPZATO™ in Liver-Dominant Metastatic Breast Cancer

April 30, 2025

NMPA accepted NDA for zurletrectinib (ICP-723) for patients with advanced solid tumors harboring NTRK gene fusions

April 22, 2025

FDA Clears IND Application for CLD-201 in Solid Tumors

April 22, 2025

Rare Pediatric Disease Designation for NEO100 in Treatment of Pediatric-Type Diffuse High-Grade Gliomas

April 22, 2025

RMAT Designation for LYL314 for the Treatment of R/R Large B-Cell Lymphoma

April 22, 2025

PTX-100 receives US FDA Fast Track Designation for the treatment of adults with R/R mycosis fungoides, the most common subtype of CTCL

April 22, 2025

sBLA submitted to FDA for use of ANKTIVA® plus BCG in BCG-unresponsive NMIBC for the indication of papillary disease

April 22, 2025

FDA clears IND application for ALX2004 in EGFR-expressing solid tumors

April 16, 2025
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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.