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FDA Clears IND Application for Ph 1 Trial of RB-164 for Hematologic and Solid Malignancies

April 2, 2025

US FDA Breakthrough Therapy Designation for Darovasertib Monotherapy in Neoadjuvant Uveal Melanoma

April 2, 2025

FDA Clears NDA to Initiate Ph 1 Clinical Trial of CER-1236 in Solid Tumors

April 2, 2025

Positive CHMP Opinion for Neoadjuvant Opdivo + Chemo Followed by Surgery and Adjuvant Opdivo for Resectable NSCLC in Patients with Tumor Cell PD-L1 Expression ≥1%

April 2, 2025

Calquence plus chemoimmunotherapy recommended for approval in the EU by CHMP for 1L MCL

April 2, 2025

FDA Approved Compassionate Use Treatment with Namodenoson in a Pancreatic Cancer Patient

March 26, 2025

FDA Orphan Drug Designation for HLX22/AC101 in Gastric Cancer

March 26, 2025

Second DSMB Issues Positive Recommendation to Continue Bria-IMT Ph 3 Study in Metastatic Breast Cancer

March 26, 2025

Azer-cel granted FDA Fast Track Designation in DLBCL

March 26, 2025

FDA Clears IND Application for Tumor-Associated Antigen Vaccine EVM14

March 26, 2025

FDA approves IND application to initiate Oncorella-1 Ph 1/2 trial of ONC175 

March 18, 2025

FDA Clears IND Application for Combination of Versamune® MUC1 and PDS01ADC to Treat Metastatic CRC

March 18, 2025

Update relating to Resminostat’s (Kinselby) Marketing Authorisation Application announced

March 18, 2025

EU authorises CTA to initiate VIDAR-1 Ph 1/2 umbrella trial in patients with mutated KRAS-positive advanced pancreatic cancer

March 18, 2025

SKB445 Receives IND Approval in solid tumors from NMPA in China

March 18, 2025

FDA Orphan Drug Designation for PEP-010 for treatment of Pancreatic Cancer

March 18, 2025

Selective ATM Inhibitor SYH2051 Obtains Clinical Trial Approval in the U.S.

March 18, 2025

U.S. FDA Orphan Drug Designation Granted to Bexobrutideg (NX-5948) for the Treatment of Waldenström Macroglobulinemia

March 18, 2025

Olverembatinib Granted Breakthrough Therapy Designation for the Treatment of Philadelphia Chromosome-Positive (Ph+) ALL

March 11, 2025

FDA Clears IND Application for CD7 UCAR T Cell Therapy in T-ALL/LBL

March 11, 2025

FDA Grants Orphan Drug Designation for Bexmarilimab in MDS

March 11, 2025

FDA’s IND Approval of LAE120 for Treatment of Advanced Solid Tumors Announced

March 11, 2025

FDA accepts Supplemental BLA for Opdivo + Yervoy for Patients with Unresectable or Metastatic MSI-H or MRD CRC

March 4, 2025

FDA clears IND application for LTZ-301 to treat R/R NHL

March 4, 2025

FDA Fast Track Designation for PYX-201 Monotherapy in Patients with Recurrent or Metastatic Head and Neck Cancer

March 4, 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.