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FDA Lifts Clinical Hold on the IOV-LUN-202 Registrational Trial in NSCLC

March 12, 2024

Orphan Drug Designation from FDA for Avutometinib Alone or in Combination With Defactinib in Recurrent Low-Grade Serous Ovarian Cancer

March 12, 2024

Amendment Filed to Initiate New Pancreatic Cancer GOBLET Cohort Supported by PanCAN

March 12, 2024

China’s NMPA Accepted Second NDA for Taletrectinib for First-Line Treatment of ROS1-Positive Lung Cancer

March 12, 2024

US FDA Grants Orphan Drug Designation For First-In-Class Autotaxin Cancer Therapy

March 12, 2024

FDA Orphan Drug Designation for A2B530 in Colorectal Cancer

March 12, 2024

FDA Clearance obtained for a First in Human Clinical Study for Stage III/IV Ovarian Cancer Treatment with Autologous Vaccine Therapy, Innocell™

March 12, 2024

FDA clears IND application for NOX-A12 Ph 2 trial in brain cancer

March 12, 2024

IMBRUVICA® (ibrutinib) Label expanded in the U.S. to Include Oral Suspension Formulation for Adult Patients in its Approved Indications

March 12, 2024

Application submitted to the EMA for DARZALEX® (daratumumab)-based quadruplet therapy for the treatment of patients with transplant-eligible, newly diagnosed multiple myeloma

March 12, 2024

Two Datopotamab Deruxtecan Applications Validated in the EU for Patients with Advanced Nonsquamous NSCLC or HR+, HER2 Negative Breast Cancer

March 12, 2024

Positive CHMP Opinion for CARVYKTI in Patients with Relapsed and Lenalidomide-Refractory Multiple Myeloma in Earlier Lines of Therapy

March 5, 2024

FDA Fast Track Designation For BST02 In Treatment Of Liver Cancer

March 5, 2024

Positive CHMP Opinion for Tislelizumab as Treatment for Non-Small Cell Lung Cancer

March 5, 2024

U.S. FDA Breakthrough Therapy Designation for BAY 2927088 for NSCLC Harboring HER2 Activating Mutations

March 5, 2024

U.S. FDA makes a decision regarding the withdrawal of Pepaxto

March 4, 2024

BLA for TEVIMBRA® (tislelizumab) for First-Line Gastric or Gastroesophageal Junction Cancers Accepted by FDA

March 4, 2024

FDA Accepts for Priority Review the sBLA for Epcoritamab (EPKINLY®) for Difficult-to-Treat R/R Follicular Lymphoma

March 4, 2024

U.S. FDA Breakthrough Therapy Designation for NVL-520

March 4, 2024

U.S. FDA Clears IND Application for CLN-619 for R/R Multiple Myeloma

March 4, 2024

US regulatory approval received to start pancreatic cancer Ph IIb trial with nadunolimab

February 26, 2024

FDA Grants Priority Review to sBLA for KEYTRUDA Plus Chemotherapy as Treatment for Primary Advanced or Recurrent Endometrial Carcinoma

February 26, 2024

Orphan Drug Designation Granted to Soquelitinib for the Treatment of T Cell Lymphoma

February 26, 2024

Approval received to initiate clinical Ph 1/2-study CARMA with CAR T-cell therapy ELC-301 in B-Cell lymphoma

February 26, 2024

Enhertu granted Priority Review in the US for patients with metastatic HER2-positive solid tumours

February 26, 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.