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FDA Orphan Drug Designation for CAN-2409 for the Treatment of Pancreatic Cancer

April 16, 2024

Type C Meeting Requested to FDA Toward Registration-Enabling Trial for Pelareorep in Breast Cancer

April 16, 2024

FDA approves IND to initiate Ph 1/2a trial of SA53-OS

April 16, 2024

U.S. FDA Orphan Drug Designation Granted to LSTA1 for the Treatment of Osteosarcoma

April 16, 2024

Fast Track Designation from the FDA for Tamibarotene for the Treatment of Newly Diagnosed Unfit AML with RARA gene overexpression

April 16, 2024

FDA Clearance To Initiate Ph 1/2 Clinical with TTX-MC138 in Advanced Solid Tumors Announced

April 16, 2024

NMPA approves sNDA for Toripalimab for the 1st-Line Treatment of Renal Cancer

April 16, 2024

FDA accepts NDA for SH-201, the first palatable oral liquid of the related chemotherapeutic agent to treat certain forms of leukemia and other cancers

April 16, 2024

Datopotamab deruxtecan BLA accepted in the US for patients with previously treated metastatic HR+ve, HER2-neg breast cancer

April 8, 2024

US FDA Fast Track designation for NOX-A12 in brain cancer

April 8, 2024

Pluvicto® pre-taxane label expansion filing planned in H2 2024 based on latest data from Ph 3 PSMAfore study

April 8, 2024

IND Application submitted to the FDA for SynKIR™-310 in R/R B-cell NHL

April 8, 2024

Zanidatamab BLA for Previously Treated HER2-Positive Metastatic Biliary Tract Cancer initiated

April 8, 2024

sNDA for Toripalimab as Perioperative Treatment for Resectable NSCLC Patients approved

April 8, 2024

China’s NMPA Accepts sBLA for enfortumab vedotin with KEYTRUDA for First-Line Treatment of Advanced Bladder Cancer

April 2, 2024

FDA Priority Review of NDA for Revumenib for the Treatment of R/R KMT2Ar Acute Leukemia

April 2, 2024

Savolitinib sNDA Accepted in China for Treatment-Naïve or Previously Treated Patients with Locally Advanced or Metastatic MET Exon 14 NSCLC

April 2, 2024

NMPA approves IND application for Equecabtagene Autoleucel in Second- and Third-Line Treatment of Multiple Myeloma

April 2, 2024

Stenoparib development Toward Regulatory Approval in Advanced Recurrent Ovarian Cancer Accelerated

April 2, 2024

PT886 granted Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma by the FDA

March 26, 2024

Positive CHMP Opinion Received for XTANDI in Additional Recurrent Early Prostate Cancer Treatment Setting

March 26, 2024

FDA issued CRLs for the BLAs for odronextamab in R/R follicular lymphoma (FL) and in R/R DLBCL, each after two or more lines of systemic therapy

March 26, 2024

FDA ODAC recommends CARVYKTI® (ciltacabtagene autoleucel) for the earlier treatment of patients with R/R multiple myeloma

March 26, 2024

FDA Accepts BLA Resubmission Of LYMPHIR™ (Denileukin Diftitox) For The Treatment Of Adults With R/R Cutaneous T-Cell Lymphoma

March 26, 2024

FDA Allows to Proceed Under IND for Alisertib in HER2-Negative, Hormone Receptor-Positive Metastatic Breast Cancer

March 26, 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.