A comprehensive view of Complete Response Letters (CRL) / Disapproval. This page highlights a small sample of our full coverage.
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Eli Lilly dumps Innovent Biologic's Tyvyt PD-1 inhibitor after FDA rebuff, nixing high-profile Chinese cancer drug
Published: December 02, 2022 by FiercePharma
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
Published: October 21, 2022 by FiercePharma
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
Published: October 19, 2022 by UPI Top News
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
Published: October 12, 2022 by CE Noticias Financieras
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
Published: September 13, 2022 by FiercePharma

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