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Linkedin

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

BLA for LYMPHIR™ (Denileukin Diftitox) For The Treatment Of Adults With R/R CTCL resubmitted

February 26, 2024

U.S. and EU Regulatory Filings for Neoadjuvant Opdivo and Chemotherapy Followed by Surgery and Adjuvant Opdivo in Resectable NSCLC accepted

February 26, 2024

U.S. FDA ODAC Meeting for Abecma in Triple-Class Exposed Multiple Myeloma Based on KarMMa-3 Study

February 26, 2024

U.S. FDA Accepts for Priority Review sNDA for Augtyro™ (repotrectinib) for the Treatment of Patients with NTRK-Positive Locally Advanced or Metastatic Solid Tumors

February 26, 2024

Datopotamab deruxtecan BLA accepted in the US for patients with previously treated advanced nonsquamous non-small cell lung cancer

February 26, 2024

FDA accepted for Priority Review the BLA for linvoseltamab for R/R multiple myeloma that has progressed after at least three prior therapies

February 26, 2024

FDA accepts sNDA for KRAZATI® (adagrasib) in Combination with Cetuximab as a Targeted Treatment Option for Patients with Previously Treated KRAS G12C-Mutated Locally Advanced or mCRC

February 26, 2024

Positive EU CHMP Opinion for KEYTRUDA in Combination With Chemotherapy as Neoadjuvant Treatment, Then Continued as Monotherapy as Adjuvant Treatment, for the Treatment of Resectable NSCLC at High Risk of Recurrence

February 26, 2024

Orphan Drug Designation Granted by US FDA for IO-202 (Anti-LILRB4) for the Treatment of Chronic Myelomonocytic Leukemia (CMML)

February 26, 2024

Submission of a Rolling NDA to the FDA for UGN-102 initiated

January 31, 2024

Positive CHMP Opinion for CAR T Cell Therapy Abecma (idecabtagene vicleucel) in Earlier Lines of Therapy for Triple-Class Exposed R/R Multiple Myeloma

January 31, 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.