EMA Safety Committee Recommends Stopping Infusions of HES Solutions, Launches Review of Janus Kinase Inhibitors

The European Medicines Agency’s (EMA) safety committee has recommended that the EU suspend authorizations for hydroxyethyl-starch (HES) solutions for infusion after concluding that the products are being administered in a…

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On Procedural Grounds, FDA Denies Citizen Petition to Look Into Data Tampering at Cassava Sciences

Amid accusations of manipulating data associated with trials for its Alzheimer’s drug candidate simufilam, Cassava Sciences had a bit of good news when the FDA denied a citizen petition pressing…

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Democrats and Advocacy Groups Press HHS to Assert ‘March-in’ Rights Over Pricy Prostate Cancer Drug Xtandi

Democrats in the U.S. House of Representatives and eight advocacy groups are pressing Department of Health and Human Services (HHS) head Xavier Becerra to use either “march-in” or government use…

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