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FDA Clears IND Application for BL-M17D1 in Advanced Solid Tumors

November 12, 2024

Applications submitted in the U.S. and EU seeking approval of DARZALEX FASPRO / DARZALEX as SC monotherapy for high-risk smoldering multiple myeloma

November 12, 2024

Orphan Drug Designation from the US FDA for LBL-034 for the Treatment of Multiple Myeloma

November 12, 2024

Orphan Drug Designation by US FDA for MB-108 (HSV-1 oncolytic virus) to Treat Malignant Glioma

November 12, 2024

NDA Submitted to the U.S. FDA for Sunvozertinib in Treating R/R NSCLC with EGFR Exon 20 Insertion Mutations

November 12, 2024

FDA Regenerative Medicine Advanced Therapy (RMAT) Designation granted to ALLO-316 for Adult Patients with Advanced or Metastatic RCC

November 5, 2024

Rolling NDA Submission to the FDA for Avutometinib Plus Defactinib as a Treatment for Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer Completed

November 5, 2024

FDA clearance to commence Ph 2 trial of leronlimab in patients with R/R microsatellite stable CRC

November 5, 2024

IND-Clearance for Werner Helicase Development Candidate IDE275 (GSK959) for a Ph 1 Study in MSI-High Solid Tumors Announced

November 5, 2024

FDA Clears IND Application for ATX-559 Ph 1 study in solid tumor patients with a focus on BRCA1/2-deficient breast cancer and MSI-H and dMMR solid tumors

October 29, 2024

FDA’s Oncologic Drugs Advisory Committee Decision on use of Multikine® in PD-L1 Negative Cancer Patients announced

October 29, 2024

FDA Clears IND Application for ADRX-0405 for the Treatment of Advanced Solid Tumors

October 29, 2024

FDA accepts NDA for UGN-102 (mitomycin) for intravesical solution for the treatment of LG-IR-NMIBC; PDUFA goal date: Jun 2025

October 22, 2024

Positive CHMP opinion for Kisqali® to help reduce risk of recurrence in people with HR+/HER2- early breast cancer

October 22, 2024

Positive guidance from the U.S. FDA on 64Cu-SAR-bisPSMA Ph 3 trial in patients with recurrence of prostate cancer

October 22, 2024

US FDA issues Study May Proceed letter for the Pilot Study of Pidnarulex PD in Patients with Advanced Solid Tumors

October 22, 2024

LP-184 Receives Fast-Track Designation in Glioblastoma from the FDA

October 22, 2024

Orphan Drug Designation for IMM-1-104 by FDA in the Treatment of Pancreatic Cancer

October 22, 2024

U.S. FDA Rare Pediatric Disease Designation (RPDD) Granted to Galinpepimut-S (GPS) for the Treatment of Pediatric AML

October 22, 2024

IND Application for Ph 3 Study of Neoadjuvant KN026 +Albumin-bound Docetaxel in Breast Cancer Approved

October 22, 2024

Positive CHMP Opinions for TEVIMBRA® as a 1L Treatment for Advanced/Metastatic Gastric or GEJ Cancer and Esophageal Squamous Cell Carcinoma

October 22, 2024

FDA Clears IND Application for Ph 1/2 ADCElerate-01 Trial of ADCE-D01 Trial in Patients with Metastatic and/or Unresectable Soft Tissue Sarcoma (STS)

October 15, 2024

Type II variation application to the EMA for DARZALEX® (daratumumab) SC-based quadruplet regimen for newly diagnosed multiple myeloma patients

October 15, 2024

FDA Grants Orphan Drug Designation to Namodenoson for Pancreatic Cancer

October 15, 2024

CRLs submitted to request lifting the clinical holds for zevorcabtagene autoleucel, satricabtagene autoleucel and CT071

October 15, 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.