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RSS FeedPosted by Michael Wonder on 14 Oct 2025
Akamis Bio receives FDA fast track designation for NG-350A for the treatment of mismatch repair proficient locally advanced rectal cancer
14 October 2025 - NG-350A is a systemically delivered oncolytic immunotherapy driving intra-tumoral expression of a CD40 agonist monoclonal antibody. ...
Posted by Michael Wonder on 24 Mar 2022
Fresenius Kabi announces FDA approval of SMOFlipid lipid injectable emulsion for paediatric patients requiring parenteral nutrition
24 March 2022 - First and only four-oil lipid injectable emulsion indicated for paediatric parenteral nutrition, including term and preterm neonates. ...
Posted by Michael Wonder on 17 Aug 2021
FDA grants accelerated approval of Jemperli (dostarlimab-gxly) for dMMR recurrent or advanced solid tumours
17 August 2021 - Second FDA approval of PD-1 antagonist antibody under clinical development for solid tumours in collaboration with GSK. ...
Posted by Michael Wonder on 05 Aug 2021
Exelixis announces U.S. FDA accepts for priority review the supplemental new drug application for Cabometyx (cabozantinib) for patients with previously treated radioactive iodine refractory differentiated thyroid cancer
5 August 2021 - U.S. Food and Drug Administration assigned a Prescription Drug User Fee Act action date of 4 December ...