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InfaCare’s Stannsoporfin For Jaundice Rebuked By US FDA Panel

 
• By Sue Sutter

Uncertainties about clinical benefit and neurodevelopmental safety drive lopsided recommendation against approval; some advisory committee members say that even FDA’s REMS proposal wouldn't be enough to allow stannsoporfin to come to market without further studies.

FDA Advisory Committee Feature image

A US FDA advisory committee found little to like in InfaCare Pharmaceutical Corp.’s application for the jaundice drug stannsoporfin May 3, concluding the efficacy and safety data were insufficient to support approval and the sponsor’s proposed voluntary risk mitigation plan was inadequate.

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Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 
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‘Pipeline In A Pill’ Or Pipe Dream? US FDA’s April Goal Dates Test Expansion Strategies

 
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EU CHMP Opinions And MAA Updates

 
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This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

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