accelerated approvals

News

FDA accelerated approval path needs improvement, says ICER

The FDA's accelerated approval route has delivered important new drugs to patients quicker, but is opaque and plagued by inconsistencies, says ICER.

News

Study points to weaknesses in FDA accelerated approval path

Less than half of the cancer therapies that were granted accelerated approval by the FDA between 2013 and 2017 showed a clinical benefit in a confirmatory trial within the

R&D

Headlines and hot topics from ASCO and BIO, with Jonah Comst...

This week, pharmaphorum editor-in-chief Jonah Comstock headed to not one, but two back-to-back events in the US.

FDA accelerated approval path needs improvement, says ICER

Study points to weaknesses in FDA accelerated approval path

Headlines and hot topics from ASCO and BIO, with Jonah Comst...

Chiesi signs $1.9bn deal to buy KalVista and its HAE drug

Using AI-driven synthetic personas to take your insights fur...

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