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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

Regulatory Applications Accepted in the U.S. and Japan for Breyanzi (lisocabtagene maraleucel) in R/R Follicular Lymphoma and R/R Mantle Cell Lymphoma

February 26, 2024

Positive pre-IND meeting with US FDA for new ovarian cancer cell therapy CTH-401

February 26, 2024

FDA accepts BLA for Afami-cel for the Treatment of Advanced Synovial Sarcoma with Priority Review

February 26, 2024

Tisotumab Vedotin MAA Validated by EMA for Treatment of Recurrent or Metastatic Cervical Cancer

February 26, 2024

EMA Orphan Drug Designation for UV1 Cancer Vaccine for the Treatment of Mesothelioma

February 26, 2024

FDA clears IND FDA Application for Allogeneic Anti-EGFR Cell Therapy ACE2016

February 26, 2024

Vepdegestrant (ARV-471) Receives FDA Fast Track Designation for the Treatment of Patients with ER+/HER2- Metastatic Breast Cancer

February 26, 2024

FDA Fast Track Designation for BXCL701 for Treatment of Small Cell Neuroendocrine Prostate Cancer (SCNC)

February 26, 2024

sBLA submitted to US FDA seeking approval of DARZALEX FASPRO)-based regimen for treatment of patients with transplant-eligible, newly diagnosed multiple myeloma

February 26, 2024

FDA Fast Track Designation granted to BNT325/DB-1305

February 26, 2024

Type II Extension of Indication Application to the EMA Seeking Approval of RYBREVANT + Lazertinib, for 1L Treatment of Patients with EGFR-Mutated NSCLC

February 26, 2024

Linvoseltamab receives EMA filing acceptance for treatment of R/R multiple myeloma

February 26, 2024

EMA Validates Type II Variation Application for PADCEV (enfortumab vedotin) with KEYTRUDA® (pembrolizumab) for 1L Treatment of Advanced Bladder Cancer

February 26, 2024

PADCEV™ (enfortumab vedotin) with KEYTRUDA® (pembrolizumab) Granted Priority Review by Japan’s MHLW for 1L Treatment of Advanced Bladder Cancer

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.