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Linkedin

HREC Approval and CTN Clearance granted from the TGA to Commence a Ph 1 Clinical Trial for INT2104 for B Cell Malignancies

July 17, 2024

Aplidin (plitidepsin) to be re-evaluated by the EMA for Multiple Myeloma

July 17, 2024

Plans for Near-Term Resubmission of NDA for 1L Treatment Option for Unresectable HCC Following Type A FDA Meeting Reported

July 17, 2024

End of Ph 2 Meeting with FDA for Annamycin in AML Completed

July 17, 2024

FDA Clears IND Application for RGT-61159 in CRC & Adenoid Cystic Carcinoma (ACC)

July 17, 2024

Application filed for for FDA Orphan Drug Designation for Namodenoson in the Treatment of Pancreatic Cancer

July 17, 2024

BLA resubmitted to the FDA for cosibelimab for patients with metastatic or locally advanced cSCC not candidates for curative surgery or curative radiation

July 9, 2024

FDA approves IND for sigx1094 for Diffuse Gastric Cancer

July 9, 2024

Japan’s PMDA clears CTN for Ph 3 MRCT of Serplulimab Combo in patients with 1L mCRC

July 9, 2024

FDA clears IND for SCG142 for patients with HPV-associated solid tumor

July 9, 2024

CHMP adopts positive opinion for BALVERSA (erdafitinib) in unresectable/metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations

July 9, 2024

NMPA accepts NDA for Tazemetostat for the Treatment of R/R Follicular Lymphoma with Priority Review Status

July 9, 2024

FDA clears IND for Oncolytic Immunotherapy VET3-TGI for Solid Tumors

July 9, 2024

Lynparza and Imfinzi combination recommended for approval in the EU by CHMP for patients with MMR-proficient advanced or recurrent endometrial cancer

July 9, 2024

FDA Granted Fast Track Designation for 225Ac-FL-020 for the Treatment of Metastatic CRPC

July 9, 2024

FDA clears IND Application for GTB-3650 for Treatment of CD33+ Leukemia

July 1, 2024

Patritumab Deruxtecan BLA Submission Receives CRL from FDA Due to Inspection Findings at Third-Party Manufacturer

July 1, 2024

FDA Clears IND Application for ADI-270 in RCC

July 1, 2024

FDA aligns on BLA resubmission strategy for cosibelimab

July 1, 2024

FDA Rare Pediatric Disease Designation Granted to SLS009 for the Treatment of Pediatric ALL

July 1, 2024

FDA Fast Track Designation for CT-0525 for the Treatment of HER2-overexpressing Solid Tumors

July 1, 2024

FDA grants Fast Track Designation for ABD-147 for the Treatment of Patients with Extensive-stage SCLC

July 1, 2024

FDA grants Fast Track Designation for TUB-040 in Platinum-resistant Ovarian Cancer

July 1, 2024

EMA Approves MDNA11 CTA to Expand Ph 1/2 ABILITY-1 Study to Europe

July 1, 2024

Odronextamab Recommended for EU Approval by the CHMP to Treat R/R Follicular Lymphoma and DLBCL

July 1, 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.