A comprehensive view of Complete Response Letters (CRL)/Disapproval. This page highlights a small sample of our full coverage.
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FDA rejects bid by Teva, MedinCell for approval of new extended-release version of subcutaneous risperidone to treat schizophrenia after positive Phase 3 results; Teva to pursue resolution of matter but analyst expects approval delay of nine to 12 months

Eli Lilly receives FDA complete response letter for investigational medicine sintilimab injection combined with pemetrexed and platinum chemotherapy for lung cancer; FDA recommends additional clinical study

Gilead announces FDA Complete Response Letter for investigational lenacapavir for treatment of HIV-1 infection; FDA cites issues related to compatibility of the drug with proposed container vial made of borosilicate glass

Merck announces FDA Complete Response Letter for its New Drug Application for gefapixant, an oral treatment for chronic cough; FDA has requested additional information related to measurement of efficacy

Takeda announces Complete Response Letter from the US FDA in response to application for oral TAK-721 as a treatment of eosinophilic esophagitis; FDA has recommended additional clinical study in order to resolve feedback

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