News Warning letter adds to Applied Tx run of bad news Applied Therapeutics gets a warning letter from the FDA over a trial of rare disease drug govorestat, which was rejected by the agency last week.
News Applied Tx craters as FDA rejects lead product candidate Applied Therapeutics plummets after the FDA turns down its marketing application for govorestat as a treatment for galactosaemia
News Applied Therapeutics slumps as FDA seeks more data on lead d... Shares in Applied Therapeutics slumped today after it said it would have to delay a US filing for its lead drug programme AT-007, following an FDA request for more data.
News FDA clears Ionis drug as first therapy for rare disease FCS Ionis Pharma's Tryngolza (olezarsen) has become the first FDA-approved drug therapy for adults with rare disease familial chylomicronaemia syndrome.
Digital Sponsored The AI effect in pharma commercial strategy: From data to re... Discover how AI is transforming the pharma commercial strategy. Unlock real-time insights & actions from data. Click here for more.