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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

BLA accepted for obecabtagene autoleucel (obe-cel) as a potential treatment for R/R Adult B-cell ALL

January 31, 2024

Fast Track Designation for Combination of Avutometinib and Sotorasib for the Treatment of KRAS G12C-Mutant NSCLC

January 23, 2024

Orphan Drug Designation Granted to PTX-252 by U.S. FDA for the Treatment of Acute Myeloid Leukaemia (AML)

January 23, 2024

Submission of Complete Response to Clinical Hold for HEMO-CAR-T IND

January 23, 2024

FDA Accepts the PMA Application for TTFields Therapy in NSCLC

January 23, 2024

TIVDAK® sBLA Accepted for Priority Review by FDA for Patients with Recurrent or Metastatic Cervical Cancer

January 17, 2024

Update on Zolbetuximab Biologics License Application in U.S.: FDA rejects the application

January 17, 2024

FDA Fast Track Designation for SLS009 for Treatment of R/R AML

January 17, 2024

ANDA for Generic LUTATHERA® (Lutetium Lu 177 Dotatate) announced

January 17, 2024

RC88 Obtained FDA Fast Track Designation

January 17, 2024

FDA Issued New Postmarketing Requirement on sNDA seeking full approval of LUMAKRAS® (sotorasib)

January 10, 2024

FDA Clears IND for SC262 for Patients with R/R B-cell Malignancies

January 10, 2024

U.S. FDA clears IND Enabling Ph 1 Initiation for OKI-219

January 10, 2024

Rinatabart Sesutecan FDA Fast Track Designation for Patients with Advanced Ovarian Cancer

January 10, 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.