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Linkedin

BLA submission of ANKTIVA planned in 2025 for 2/3L treatment of patients with NSCLC, who are progressing on checkpoint inhibitors

January 21, 2025

IND Clearance from FDA to Proceed with Ph 2 Study of TYRA-300 in NMIBC (SURF302)

January 15, 2025

Datopotamab deruxtecan granted Priority Review in the US for patients with previously treated advanced EGFR-mutated NSCLC

January 15, 2025

FDA clears IND for Ph 1/2 clinical trial of REC-4539 in SCLC and MHRA clears IND for Ph 1 clinical trial of REC-3565 for B-cell malignancies

January 15, 2025

US FDA Breakthrough Therapy Designation Granted to Letetresgene Autoleucel (lete-cel) for Treatment of Myxoid/Round Cell Liposarcoma (MRCLS)

January 15, 2025

Orphan Drug Designation from the US FDA for Amezalpat to Treat Patients with HCC

January 15, 2025

FDA clears IND application for QTX3544 enabling initiation of Ph 1 clinical trial

January 15, 2025

FDA Granted Priority Review to Sunvozertinib NDA

January 15, 2025

GSK’227 receives US FDA Breakthrough Therapy Designation in late-line R/R osteosarcoma

January 15, 2025

Invikafusp Alfa (STAR0602) Receives US FDA Fast Track Designation for Treatment of Unresectable, Locally Advanced, or Metastatic TMB-H CRC

January 15, 2025

IND submission for NDI-219216 completed with plans to initiate clinical trial in 1H 2025 for treatment of MSI-H tumors

January 15, 2025

sNDA for cabozantinib in pNET and epNET patients no longer the subject of discussion at an ODAC meeting

January 15, 2025

R289 Granted Orphan Drug Designation by the FDA for MDS

January 15, 2025

Azenosertib Fast Track Designation granted for Cyclin E1 positive patients by US FDA

January 15, 2025

FDA Fast Track Designation for LYT-200 in AML

January 15, 2025

FDA Fast Track Designation for BBO-8520 for KRASG12C-Mutated Metastatic NSCLC

January 15, 2025

SNB-101 receives IND clearance from FDA for Ph 1b/2 trial in SCLC patients

January 15, 2025

Additional FDA Fast Track Designation Granted to Emiltatug Ledadotin (XMT-1660)

January 15, 2025

Novel CPT1 pathway inhibitor received Orphan Drug Designation from the FDA for treating malignant gliomas

January 15, 2025

FDA Fast Track Designation for LOAd703 for the treatment of Pancreatic Cancer

January 15, 2025

ELC-100 receives Orphan Drug Designation in the U.S. for the treatment of pancreatic neuroendocrine tumors

January 15, 2025

IND for IM-1021 Cleared by FDA

January 15, 2025

Orphan Drug Designation from the US FDA for Amezalpat to Treat Patients with HCC

January 7, 2025

FDA Acceptance and Priority Review of NDA for Avutometinib + Defactinib for the Treatment of Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer Announced

January 7, 2025

Update Provided on Paxalisib Regulatory Pathway Following Type C Meeting with FDA

January 7, 2025
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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.