Tag: accelerated approval

FDA sets back Travere’s plans for kidney disease drug approval

May 26, 2021

Via: FierceBiotech

The 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 […]

FDA, News, Regulations

FDA commish finding his feet, COVID-19, and chaotic communication hitting speedy approvals

August 26, 2020

Via: FierceBiotech

The 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 […]

Tag: accelerated approval

FDA sets back Travere’s plans for kidney disease drug approval

FDA commish finding his feet, COVID-19, and chaotic communication hitting speedy approvals

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Tag: accelerated approval

FDA sets back Travere’s plans for kidney disease drug approval

FDA commish finding his feet, COVID-19, and chaotic communication hitting speedy approvals

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Latest Publications

Novo Nordisk Foundation to Establish New Cell Therapy Manufacturing Facility in Denmark

FDA staff hold ‘major concerns’ with Brainstorm ALS therapy, documents show

Many Americans Frustrated in Search for Low-Cost COVID Boosters