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NDA submitted to US FDA for Accelerated Approval for Patients with Recurrent H3 K27M-Mutant Diffuse Glioma

January 7, 2025

US FDA Accepts for Priority Review NDA for Taletrectinib for the Treatment of Advanced ROS1+ve NSCLC

December 31, 2024

Datopotamab Deruxtecan Application in the EU for Patients with Advanced non-sqNSCLC Voluntarily Withdrawn

December 31, 2024

FDA issues CRL for BLA for fixed combination of amivantamab and human hyaluronidase for SC amivantamab in patients with NSCLC with EGFR mutations

December 26, 2024

U.S. FDA Grants Breakthrough Therapy Designation to Trodelvy® (sacituzumab govitecan-hziy) for 2L Treatment of ES-SCLC

December 26, 2024

RAD 202 receives approval to start Ph 1 therapeutic trial

December 25, 2024

Type II variation application submitted to the EMA seeking approval of IMBRUVICA in adult patients with 1L MCL eligible for auto SCT

December 25, 2024

U.S. FDA Fast Track Designation for NX-5948 for the Treatment of R/R Waldenstrom’s Macroglobulinemia

December 25, 2024

Positive CMC Meeting with FDA for IMNN-001 in Treatment of Advanced Ovarian Cancer Announced

December 25, 2024

GSK227 receives EMA Priority Medicines (PRIME) Designation in relapsed ES-SCLC

December 18, 2024

Jemperli (dostarlimab-gxly) receives US FDA Breakthrough Therapy Designation for locally advanced dMMR/MSI-H rectal cancer

December 18, 2024

Positive EU CHMP Opinion for WELIREG® (belzutifan) as Treatment for Adult Patients With Certain Types of VHL Disease-Associated Tumors and for Certain Previously Treated Adult Patients With Advanced RCC

December 18, 2024

NDA for Dordaviprone for Accelerated Approval to U.S. FDA for Patients with Recurrent H3 K27M-Mutant Diffuse Glioma to be submitted Before Year-End

December 18, 2024

Jemperli (dostarlimab) + chemo receives positive CHMP opinion to expand approval to all adult patients with primary advanced or recurrent endometrial cancer

December 18, 2024

FDA Clearance received to Administer AIV001 in Facial Skin by Intradermal Injection for Superficial and Nodular Superficial Basal Cell Carcinoma (sBCC and nBCC)

December 18, 2024

FDA accepts IND application for initiation of a Ph 1 clinical trial to evaluate LNCB74 in multiple cancers

December 18, 2024

Orphan Drug Designation from FDA for PLT012 in Treatment of Liver and Intrahepatic Bile Duct Cancer

December 17, 2024

FDA Granted Fast Track Designation for IMM-1-104 in Advanced Melanoma

December 17, 2024

LP-184 Receives Second Fast Track Designation from FDA for Treatment of TNBC

December 10, 2024

Datopotamab deruxtecan granted breakthrough therapy designation in US for patients with previously treated advanced EGFR-mutated NSCLC

December 10, 2024

Blenrep (belantamab mafodotin) combination accepted for priority review in China in R/R multiple myeloma

December 10, 2024

Regulatory Update Related to sNDA for Cabozantinib (CABOMETYX®) for the Treatment of Patients with Previously Treated Advanced NETs provided

December 10, 2024

NMPA approves IND for Ph 2 Trial of HLX22

December 10, 2024

NMPA approves IND for a Ph 1b/2 Clinical Trial of PD-L1-Targeting ADC HLX43

December 10, 2024

R289 Granted Fast Track Designation by the FDA for Lower-Risk MDS

December 10, 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.