FDA approves 5 new costly drugs well ahead of PDUFA dates
Since 21 October, the FDA has been on a tear in approving five new drugs (all with list prices of more than $100,000 per year) months ahead of when they were expected to be approved.
For instance, the FDA signed off on Vertex Pharmaceuticals’ Trikafta (elexacaftor/ivacaftor/tezacaftor), a new treatment for those with the most common cystic fibrosis mutation, after only three months of review and well ahead of its 19 March 2020 user fee action date.
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