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Linkedin

IND Submission to US FDA for Pilot Study of Pidnarulex Pharmacodynamics in Patients with Advanced Solid Tumors sponsored by NCI

September 24, 2024

FDA-Authorized Expanded Access Policy for Metastatic Breast Cancer Patients Announced

September 24, 2024

FDA Approves IDE to Initiate Multi-Center Investigator-Initiated Study of Alpha DaRT® in Immunocompromised Patients with Recurrent cSCC

September 24, 2024

DARZALEX® (daratumumab)-based quadruplet regimen receives positive CHMP opinion for transplant-eligible patients with newly diagnosed multiple myeloma

September 24, 2024

Positive EU CHMP Opinions for KEYTRUDA Regimens as Treatment for Patients With cervical cancer and endometrial carcinoma

September 24, 2024

RMAT Designation from FDA for P-BCMA-ALLO1 to Treat R/R Multiple Myeloma

September 18, 2024

Positive Pre-IND FDA Meeting for Bria-PROS+ for Prostate Cancer Announced

September 18, 2024

FDA Orphan Drug Designation Granted to Tebapivat (AG-946) for Treatment of MDS

September 17, 2024

FDA Orphan Drug Designation for Elraglusib for Treatment of Soft Tissue Sarcomas

September 17, 2024

Successful pre-BLA meeting with the US FDA to support BLA for RP1 (vusolimogene oderparepvec) in anti-PD1 failed melanoma via the accelerated approval pathway in 2H 2024 announced

September 17, 2024

FDA cleared the NCI-sponsored IND application for cirtuvivint

September 17, 2024

FDA Clears IND Application for Ph 1/2 Clinical Trial of an AAV-delivered Cancer Immunotherapy, VNX-101

September 17, 2024

FDA grants RMAT Designation for OBX-115 for the Treatment of Advanced Melanoma

September 10, 2024

Fast Track Designation Granted for VMT01 for the Diagnosis & Treatment of MC1R-Positive Melanoma

September 10, 2024

Pol θ inhibitor SIM0508 obtained IND approval from US FDA

September 10, 2024

FDA Granted Fast Track Designations to CB-010 in Refractory SLE and to CB-012 in R/R AML

September 10, 2024

Fast Track Designation from FDA for IBI363 as Monotherapy for Advanced Melanoma

September 10, 2024

FDA Clears IND Application for APTN-101 in Glioblastoma

September 10, 2024

FDA Clears IND Application for MDG1015 for Multiple Solid Tumor Indications

September 10, 2024

FDA Orphan Drug Designation for ABD-147 for the Treatment of Neuroendocrine Carcinoma

September 10, 2024

Certepetide Granted FDA Orphan Drug Designation for the Treatment of Cholangiocarcinoma

September 10, 2024

Orphan Drug Designation Granted by the FDA for NXP800 for the Treatment of ARID1a-deficient Ovarian, Fallopian Tube, and Primary Peritoneal Cancers

September 3, 2024

sNDA for fruquintinib + paclitaxel for the treatment of 2L advanced gastric or GEJ adenocarcinoma voluntarily withdrawn in China

September 3, 2024

FDA Clears IND application for GT201 following its Chinese IND Approval

September 3, 2024

CDE of NMPA Approves to Initiate Ph 3 Trial of 9MW2821 for Urothelial Carcinoma in Combination with PD-1 Inhibitor

September 3, 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.