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U.S. FDA Grants Orphan Drug Designation to ABM-1310 for the Treatment of Patients with Glioblastoma Harboring BRAF V600 Mutation

August 9, 2023

FDA sends CRL for LYMPHIR™ (Denileukin Diftitox) for the Treatment of Patients with R/R CTCL

August 9, 2023

FDA Orphan Drug Designation granted to Elraglusib for Treatment of Pancreatic Cancer

August 9, 2023

FDA Grants Fast Track designation to IVS-3001 for the Treatment of Renal Cell Carcinoma

August 2, 2023

EMA Approves Clinical Trial Application (CTA) for AVC-201 for the Treatment of R/R AML and other CD123 Hematological Malignancies

August 2, 2023

CHMP Positive Opinion for JZP458 for the Treatment of Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma

August 2, 2023

FDA clears IND application for first-in-class T-Cell Receptor Natural Killer (TCR-NK) cell therapy for multiple myeloma

August 2, 2023

FDA Grants Fast Track Designation to ARX517 for the Treatment of mCRPC

July 27, 2023

Favorable IDMC Recommendation to Continue Ph 3 PANOVA-3 Clinical Trial of Tumor Treating Fields Therapy in Pancreatic Cancer

July 27, 2023

FDA grants Fast Track Designation to Selinexor for the Treatment of Myelofibrosis

July 27, 2023

EMA provides negative Review in the European Union of KRAZATI (adagrasib) for the Treatment of Advanced NSCLC with a KRAS G12C Mutation

July 27, 2023

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
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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.