- The FDA has granted Breakthrough Therapy Designation to AstraZeneca’s (NASDAQ:AZN) Farxiga for the treatment of patients with chronic kidney disease, with and without type-2 diabetes.
- Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.
- https://seekingalpha.com/news/3619311-astrazeneca-s-farxiga-nabs-accelerated-review-in-u-s-for-kidney-disease
Friday, October 2, 2020
AstraZeneca’s Farxiga nabs accelerated review in U.S. for kidney disease
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