May 26, 2021
Via: FierceBiotechThe FDA has crushed Travere Therapeutics’ hopes of seeking accelerated approval in a rare kidney disorder on the strength of existing interim data from a phase 3 clinical trial. Travere said it may have enough data to meet the FDA’s […]
August 26, 2020
Via: FierceBiotechThe FDA’s accelerated approvals program is on shaky ground after a series of surprise rejections, poor communication and COVID-19-focused staff. This is according to analysis by an anonymous FDA consultant out of regulatory firm Prevision Policy, speaking to analysts at […]
March 30, 2023
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March 16, 2023
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