InfaCare’s Stannsoporfin For Jaundice Rebuked By US FDA Panel
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.
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US FDA issued at least seven rejections to novel products; opioid analgesic sponsors had very little success, while biosimilar developers had a so-so year.
Ten novel agents are among the pending applications with user fee goal dates in August 2018.
Insys' Sublingual Buprenorphine Spray Fails At US FDA Panel, But Some Members See Future In Limited Role
Main concerns involved the delayed onset to meaningful pain relief and the safety signal of hypoxia.