Posts

4 years after FDA snub, GSK partnership propels Spero’s Utebzi across approval finish line

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Biogen Plans Resubmission After FDA Declines High-Dose Spinraza for SMA, Requests More Production Information

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FDA Rejects Scholar Rock's SMA Drug Due to Catalent Indiana Manufacturing Issues

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FDA Rejects Lundbeck and Otsuka's Rexulti for PTSD on Insufficient Efficacy Evidence

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Replimune Awaits FDA Direction After Complete Response Letter for Advanced Melanoma Therapy

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Replimune's Shares Plunge After FDA Rejects Melanoma Drug Application

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FDA Rejects Roche’s Columvi for Earlier-Line Diffuse Large B-Cell Lymphoma

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FDA Declines Approval of Ultragenyx's Sanfilippo Gene Therapy Due to Manufacturing Issues

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