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Paxalisib Receives Fast Track Designation From FDA For Treatment Of Solid Tumor Brain Mets Harboring PI3K Pathway Mutations In Combination With Radiation Therapy

July 11, 2023

FDA Grants Priority Review for Zolbetuximab Biologics License Application

July 11, 2023

Positive guidance from US FDA on Cu-64 SAR-bisPSMA Phase III trial in prostate cancer

July 11, 2023

FDA Clears Investigational New Drug Application for CFT8919 Targeting EGFR L858R for Non-Small Cell Lung Cancer

July 11, 2023

FDA Clears IND Application for P-CD19CD20-ALLO1 Dual CAR-T for B-Cell Malignancies

July 11, 2023

Design for Confirmatory Trial of Avutometinib and Defactinib in Recurrent Low-Grade Serous Ovarian Cancer Announced

July 11, 2023

The European Commission Grants Orphan Drug Designation to Temferon™ for Treatment of Glioma

July 11, 2023

U.S. FDA grants Fast Track Designation to REQORSA® in Combination with Tecentriq® for the Treatment of Small Cell Lung Cancer

July 5, 2023

Zenocutuzumab granted Breakthrough Therapy Designation by US FDA for the treatment of NRG1+ pancreatic cancer

July 5, 2023

FDA OKays Proceeding with Phase 1/2 Trials of NEO212 for Primary Brain Tumors and for Brain Metastasis in Combination with Standard of Care Therapy

July 5, 2023

GAVRETO® (pralsetinib) sNDA approval by China NMPA for first-line treatment of patients with locally advanced or metastatic RET fusion-positive NSCLC

July 5, 2023

U.S. Expanded Access Protocol for Imetelstat in Lower Risk MDS announced

July 5, 2023

CHMP Positive Opinion for Trodelvy in Pre-Treated HR+/HER2- Metastatic Breast Cancer

June 28, 2023

FDA Orphan Drug Designation for ERAS-801 for the Treatment of Malignant Glioma

June 28, 2023

FDA Orphan Drug Designation for KT-253 for the Treatment of AML

June 28, 2023

Epcoritamab Added to NCCN Guidelines for ‘B-Cell Lymphomas’

June 28, 2023

FDA accepts sNDA for Onivyde regimen in first-line metastatic pancreatic ductal adenocarcinoma

June 21, 2023

FDA extends review period for momelotinib

June 21, 2023

FDA gives go-ahead to Proceed with STAR-LLD Lenalidomide Phase 1b Clinical Trial in Multiple Myeloma

June 21, 2023

505(b)(2) NDA Approval granted from FDA for PEMRYDI RTU®, a Ready-to-Use Oncology Injectable

June 21, 2023

6-Year OS Results Added to US Prescribing Information for ADCETRIS® (brentuximab vedotin) as 1L Treatment for Advanced Hodgkin Lymphoma

June 21, 2023

Partial Clinical Hold on UP-NEXT and UPGRADE-A Clinical Trials announced

June 21, 2023

Capivasertib in combination with Faslodex granted Priority Review in the US for patients with advanced HR-positive breast cancer

June 21, 2023

sBLA accepted for priority review for Jemperli + chemo For The Treatment of dMMR/MSI-H Primary Advanced Or Recurrent Endometrial Cancer

June 14, 2023

FDA Accepts Application for KEYTRUDA Plus Chemotherapy as Treatment for Advanced or Unresectable Biliary Tract Cancer

June 14, 2023
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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.