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Setback: Eli Lilly- Innovent lung cancer drug Sintilimab rejected by USFDA
FDA and its advisers had raised concerns over the lack of population diversity in a single-country trial.
New Delhi: The U.S. Food and Drug Administration has declined to approve Eli Lilly and partner Innovent Biologics Inc's lung cancer drug that had been studied only in China, Lilly said on Thursday.The decision comes after a panel of advisers to the regulator in February recommended that Lilly and China-based Innovent should be required to conduct a trial of sintilimab that is applicable to...
New Delhi: The U.S. Food and Drug Administration has declined to approve Eli Lilly and partner Innovent Biologics Inc's lung cancer drug that had been studied only in China, Lilly said on Thursday.
Ruchika Sharma joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751