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Latest From Vivus, Inc.
‘Stop Fighting Us’ On Inspections, US FDA’s Califf Tells Industry; Foods Modernization Will Bring ‘Big Change’ To Drug Quality Systems
Commissioner Califf underscores need to keep inspections systems ‘tuned up’ to prevent manufacturers from ‘losing their edge’ on quality.
Harbinger Health CEO Stephen Hahn On Early Cancer Detection To ‘Move The Needle’ On Survival
Medtech Insight spoke with Stephen Hahn, ex-FDA commissioner and CEO of Harbinger Health, who attended SXSW, about the firm’s blood-based cancer test in development.
Astellas Misses Again On Xospata Label Expansion Effort
A Phase III disappointment in a maintenance therapy setting for FLT3-mutated acute myeloid leukemia is yet another failed attempt by Astellas to add to Xospata’s label since US FDA approval in 2018.
China New Government Policies Taking Shape As Two Sessions Underway
Moderate growth goal and lingering impact from COVID policies dampen prospects of a quick recovery for China.
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