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Linkedin

FDA accepts Filing of NDA for Rivoceranib + Camrelizumab as a First-line Treatment for Unresectable HCC

July 27, 2023

Positive CHMP Opinion for Epcoritamab (TEPKINLY®) for the Treatment of Adults with R/R DLBCL

July 27, 2023

Positive EU CHMP Opinion for KEYTRUDA + Trastuzumab + Chemo as 1L Treatment for HER2-Positive Advanced GEJ Adenocarcinoma Expressing PD-L1 (CPS ≥1)

July 27, 2023

FDA Grants Orphan Drug Designation to SNB-101 for SCLC

July 27, 2023

Positive CHMP Opinions for TALVEY (talquetamab) and TECVAYLI (teclistamab) for the Treatment of Patients with R/R Multiple Myeloma

July 27, 2023

FDA granted Fast Track Designation for REQORSA® Immunogene Therapy for patients with extensive-stage small cell lung cancer (ES-SCLC)

July 19, 2023

sNDA submitted to FDA for BRUKINSA + obinutuzumab in R/R follicular lymphoma

July 19, 2023

FDA clears FDA INDA for CFT8919, an Orally Bioavailable BiDAC™ Degrader Targeting EGFR L858R for Non-Small Cell Lung Cancer

July 19, 2023

FDA Clears SP-3164 IND Application to Begin Ph 1 Trial in R/R NHL Patients

July 19, 2023

FDA Orphan Drug Designation for Padeliporfin VTP in Pancreatic Cancer

July 19, 2023

Registrational Pivotal Phase III Study of Olverembatinib for the First-Line Treatment of Patients with Ph+ ALL Approved by the CDE in China

July 19, 2023

Orphan Drug Designation for First-In-Class Trispecific Antibody, ISB 2001

July 19, 2023

Regulatory and Clinical Updates for TIL Therapy in Advanced NSCLC provided; positive FDA Feedback Supports IOV-LUN-202 Trial Design for Accelerated Approval of TIL Therapy in Post-Anti-PD-1 Advanced NSCLC

July 19, 2023

Full FDA Review for HEMO-CAR-T IND Announced

July 19, 2023

Paxalisib Receives Fast Track Designation From FDA For Treatment Of Solid Tumor Brain Mets Harboring PI3K Pathway Mutations In Combination With Radiation Therapy

July 11, 2023

FDA Grants Priority Review for Zolbetuximab Biologics License Application

July 11, 2023

Positive guidance from US FDA on Cu-64 SAR-bisPSMA Phase III trial in prostate cancer

July 11, 2023

FDA Clears Investigational New Drug Application for CFT8919 Targeting EGFR L858R for Non-Small Cell Lung Cancer

July 11, 2023

FDA Clears IND Application for P-CD19CD20-ALLO1 Dual CAR-T for B-Cell Malignancies

July 11, 2023

Design for Confirmatory Trial of Avutometinib and Defactinib in Recurrent Low-Grade Serous Ovarian Cancer Announced

July 11, 2023

The European Commission Grants Orphan Drug Designation to Temferon™ for Treatment of Glioma

July 11, 2023

U.S. FDA grants Fast Track Designation to REQORSA® in Combination with Tecentriq® for the Treatment of Small Cell Lung Cancer

July 5, 2023

Zenocutuzumab granted Breakthrough Therapy Designation by US FDA for the treatment of NRG1+ pancreatic cancer

July 5, 2023

FDA OKays Proceeding with Phase 1/2 Trials of NEO212 for Primary Brain Tumors and for Brain Metastasis in Combination with Standard of Care Therapy

July 5, 2023

GAVRETO® (pralsetinib) sNDA approval by China NMPA for first-line treatment of patients with locally advanced or metastatic RET fusion-positive NSCLC

July 5, 2023
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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.