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FDA Clearance received to Administer AIV001 in Facial Skin by Intradermal Injection for Superficial and Nodular Superficial Basal Cell Carcinoma (sBCC and nBCC)

December 18, 2024

FDA accepts IND application for initiation of a Ph 1 clinical trial to evaluate LNCB74 in multiple cancers

December 18, 2024

Orphan Drug Designation from FDA for PLT012 in Treatment of Liver and Intrahepatic Bile Duct Cancer

December 17, 2024

FDA Granted Fast Track Designation for IMM-1-104 in Advanced Melanoma

December 17, 2024

LP-184 Receives Second Fast Track Designation from FDA for Treatment of TNBC

December 10, 2024

Datopotamab deruxtecan granted breakthrough therapy designation in US for patients with previously treated advanced EGFR-mutated NSCLC

December 10, 2024

Blenrep (belantamab mafodotin) combination accepted for priority review in China in R/R multiple myeloma

December 10, 2024

Regulatory Update Related to sNDA for Cabozantinib (CABOMETYX®) for the Treatment of Patients with Previously Treated Advanced NETs provided

December 10, 2024

NMPA approves IND for Ph 2 Trial of HLX22

December 10, 2024

NMPA approves IND for a Ph 1b/2 Clinical Trial of PD-L1-Targeting ADC HLX43

December 10, 2024

R289 Granted Fast Track Designation by the FDA for Lower-Risk MDS

December 10, 2024

FDA Grants Fast Track Designation to CRB-701 for the Treatment of R/R Metastatic Cervical Cancer

December 10, 2024

FDA Grants Breakthrough Therapy Designation to Sacituzumab Tirumotecan (sac-TMT) for the Treatment of Certain Patients With Previously Treated Advanced or Metastatic Nonsquamous NSCLC With EGFR Mutations

December 10, 2024

FDA accepts sBLA for Columvi combination for people with R/R DLBCL

December 10, 2024

PT217 granted Fast Track Designation by the FDA for NEPC

December 10, 2024

FDA granted RMAT designation to acimtamig and AlloNK (AB101) for the treatment of R/R HL

December 10, 2024

Outcomes of Type D meeting with FDA to obtain guidance on the design of a Ph 3 study of VCN-01 + chemo in metastatic pancreatic adenocarcinoma (PDAC) announced

December 10, 2024

AdAPT-001 Receives FDA Fast Track Designation for Recurrent or Refractory Soft Tissue Sarcoma Treatment

December 10, 2024

FDA Orphan Drug Designation for Azeliragon for the Treatment of Brain Metastasis From Breast Cancer

December 10, 2024

FDA Clears Investigational New Drug Application for OP-3136

December 10, 2024

Imfinzi granted Priority Review in the US for patients with muscle-invasive bladder cancer

December 10, 2024

FDA Clears IND Application for AI-081 in Advanced Solid Tumors

December 9, 2024

FDA Fast Track Designation For LBS-007

December 4, 2024

Regulatory Update Related to sNDA for Cabozantinib (CABOMETYX) for the Treatment of Patients with Previously Treated Advanced NET Provided

December 4, 2024

R289 Granted Fast Track Designation by the FDA for Lower-Risk MDS

December 4, 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.