Novartis’ Entresto Gains US FDA Panel Nod For New Heart Failure Claim
But advisory committee members debate how to define the target population for a new indication, shying away from use of ‘preserved’ to characterize heart failure patients with ejection fraction levels below normal but greater than the definition of ‘reduced’ EF.
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Keeping Track: Novartis Entresto Wins Expanded Heart Failure Claim; Padcev, Vicineum Seek Bladder Cancer Approvals
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Dermatology, chronic kidney disease and liver disease therapies stand out in a crowd of user fee goals that is actually bigger than at the same point in 2020.
The fourth quarter proved to be challenging for Novartis, with its dermatology, ophthalmology and oncology products – and Zolgensma – feeling the impact of COVID-19 lockdowns. The company is hoping for much better things in the second part of 2021.