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Linkedin

FDA Updates Action Date for Subcutaneous Nivolumab (nivolumab and hyaluronidase); new PDUFA: December 29, 2024

May 29, 2024

FDA grants Breakthrough Therapy Designation to inavolisib for advanced HR-positive, HER2-negative breast cancer with a PIK3CA mutation

May 29, 2024

NMPA of China Accepted and Granted Priority Review Designation to the NDA for Glecirasib

May 29, 2024

FDA Grants Orphan Drug Designation to Azeliragon for Pancreatic Cancer

May 29, 2024

RMAT and PRIME Designations granted to WU-CART-007

May 29, 2024

Fast Track Designation Granted by the U.S. FDA for VCN-01 for the Treatment of Metastatic Pancreatic Cancer

May 29, 2024

Rolling Submission of NDA to FDA initiated for Seeking Accelerated Approval of Avutometinib and Defactinib Combination for the Treatment of Adult Patients with Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer

May 29, 2024

Petosemtamab granted Breakthrough Therapy Designation by the U.S. FDA

May 21, 2024

US FDA accepts Protocol for New Randomized Ph 2 Study of NBTXR3 for Patients with Stage 3 Lung Cancer

May 21, 2024

China CDE Clearance for Ph 3 Trial of KRAS G12C Inhibitor Glecirasib in Patients with CRC Announced

May 21, 2024

Paediatric Investigation Plan Waiver Received from the European Medicines Agency for Certepetide in Pancreatic Cancer

May 21, 2024

IND Clearance from the FDA for SynKIR™-310 in R/R B-cell NHL

May 21, 2024

FDA Grants Type B End-of-Phase 2 Meeting to Discuss BOT/BAL Therapy for R/R Metastatic CRC

May 21, 2024

U.S. FDA Breakthrough Therapy Designation for NVL-655

May 21, 2024

FDA Grants Orphan Drug Designation to 9MW2821

May 15, 2024

U.S. FDA Accepts and grants Priority Review of BLA for Zeno for the Treatment of NRG1+ NSCLC and PDAC

May 15, 2024

FDA approves IND of EB virus-related mRNA vaccine, WGc-043

May 14, 2024

FDA grants Fast Track Designation for SCLC for SNB-101 

May 14, 2024

FDA clears IND application for EIS-12656

May 14, 2024

FDA clears IND application for BA3361, a CAB-Nectin-4 Antibody Drug Conjugate for the Treatment of Multiple Tumors

May 14, 2024

China NMPA Grants IND Clearance for ADRX-0706, a Novel Nectin-4 ADC for the Treatment of Advanced Solid Tumors

May 14, 2024

U.S. FDA accepts BLA for Subcutaneous Nivolumab (nivolumab and hyaluronidase)

May 7, 2024

Submission of New Drug Application for Glecirasib announced

May 7, 2024

Next generation selective RET inhibitor EP0031/A400 cleared to start Ph 2 development

May 7, 2024

FDA Clears IND Application for Ph 1 Trial of CTIM-76

May 7, 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.