Watching The Review Clock: Are US FDA Goal Date Extensions Reason For Optimism?
Novel agents that received three-month user fee goal date extensions have a slightly higher approval rate than novel applications overall.
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The Biogen Alzheimer’s product saw its ‘likelihood of approval’ score from Biomedtracker change directions multiple times as it moved through clinical trials and US FDA review.
Medicare may look to bolster evidence on Biogen’s potential Alzheimer’s treatment, if approved, with a national coverage decision requiring the collection of clinical data in the postmarket setting.
Keeping Track: US FDA Acts On 5 Novel Drugs: Approval For Fotivda, Pepaxto, Azstarys; CRLs For Defencath and Oral Paclitaxel
The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker