Tag Archives: Food and Drug Administration

FDA Gives Nod to Fresenius Kabi’s Tyenne®: A Dual-Format Tocilizumab Biosimilar Advancement

(IN BRIEF) Fresenius Kabi announces FDA approval of Tyenne® (tocilizumab-aazg), the first tocilizumab biosimilar offering both IV and subcutaneous formulations. This marks a significant milestone in the company’s growth strategy (#FutureFresenius) and expands treatment options for inflammatory, autoimmune diseases, and … Read the full press release

FDA Accepts AstraZeneca’s NDA for Capivasertib Combination Therapy in Advanced Breast Cancer

(IN BRIEF) AstraZeneca’s new drug application (NDA) for capivasertib, in combination with Faslodex, has been accepted and granted Priority Review by the US FDA for the treatment of advanced breast cancer. The NDA is being reviewed under Project Orbis, which … Read the full press release