A comprehensive view of Complete Response Letters (CRL)/Disapproval. This page highlights a small sample of our full coverage.
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Recent Articles

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Eli Lilly dumps Innovent Biologic's Tyvyt PD-1 inhibitor after FDA rebuff, nixing high-profile Chinese cancer drug

FDA panel votes 14-1 to remove Covis Pharma’s injectable Makena preterm birth medicine from the market; Covis pledges to work with FDA to clarify next steps in the process

FDA holding advisory committee meetings to remove Covis Pharma’s injectable pregnancy drug Makena from market because agency claims drug does not work; drug is intended to reduce risk of preterm births

FDA declines approval of Supernus Pharmaceuticals’ SPN-830 apomorphine infusion pump for continuous treatment of motor fluctuations in Parkinson's disease; FDA requests additional information, analysis related to the device

Swiss pharma firm ObsEva to cut 70% of staff after FDA rejects linzagolix uterine fibroids candidate; move will save US$7.6M, with remaining staff to support agreements with other companies to develop, commercialize preterm labor, fertility treatments

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