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US FDA accepts for priority review sBLA of Jemperli (dostarlimab) + chemo to include all adult patients with primary advanced or recurrent endometrial cancer

May 1, 2024

FDA Fast Track Designation for the Investigation of CTX-009 in Combination with Paclitaxel for the Treatment of Previously-treated Patients with Metastatic or Locally Advanced Biliary Tract Tumors

May 1, 2024

FDA Fast Track Designation for DVX101 (Dilanubicel) for the Treatment of AML

May 1, 2024

FDA Approves GFH925 (KRAS G12C Inhibitor) Monotherapy trial in Ph 3 Registrational Study Treating Metastatic CRC

May 1, 2024

Breakthrough Therapy Designation for Ziftomenib in NPM1-Mutant AML

May 1, 2024

FDA Clears IND Application for Novel SIGLEC 10 Immune Checkpoint Inhibitor ONC-841 for Solid Tumors

May 1, 2024

Feedback from FDA following Type B meeting encourages clinical development of rupitasertib in advanced breast cancer

May 1, 2024

Positive CHMP opinion for RYBREVANT (amivantamab) in combination with chemotherapy for the 1L treatment of patients with advanced NSCLC with activating EGFR exon 20 insertion mutations

May 1, 2024

CHMP Adopts Positive Opinion Recommending Approval of Opdivo in Combination with Cisplatin and Gemcitabine for the 1L Treatment of Adult Patients with Unresectable or Metastatic Urothelial Carcinoma

May 1, 2024

Ph 2/3 pivotal trial design and protocol for HB-200 + Keytruda in 1L HPV16+ recurrent or metastatic oropharyngeal squamous cell carcinoma (OPSCC) aligned with FDA feedback

May 1, 2024

Truqap plus Faslodex recommended for approval in the EU by CHMP for patients with advanced ER-positive breast cancer

May 1, 2024

EMA Grants Orphan Drug Designation for Annamycin for AML

April 23, 2024

FDA Orphan Drug Designation and completion of FDA INTERACT meeting for BVX001 in the treatment of AML announced

April 23, 2024

IND Application for the Clinical Trial of HLX53 in Combination with HANSIZHUANG Plus HANBEITAI for the 1L Treatment of Locally Advanced or Metastatic HCC Patients Approved by NMPA

April 23, 2024

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
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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.