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Gilead/Galapagos gets a setback for filgotinib, its JAK1 inhib, that was poised to be the next approved RA drug by FDA. Instead the FDA issued a complete response letter; citing concerns over sperm studies (MANTA, MANTA-RAy) & 200 mg dose. Delay till 2021? https://t.co/H0rLjOMXq8 https://t.co/vb4FDUUVoS
Dr. John Cush
Aug-23-2020
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