Gilead’s RA Hopeful Filgotinib Hit By Complete Response Letter

FDA Concerned About High Dose And Testicular Side Effects

Complete Response Letter is a major setback for Gilead and its partner Galapagos.

two hands of an elderly woman sitting on a chair - Image — • Source: Shutterstock

Gilead Sciences, Inc. has received a complete response letter (CRL) from the US Food and Drug Administration for filgotinib, its blockbuster prospect for rheumatoid arthritis, because of safety concerns.

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