Posts

Production problems hamper Lantheus bid for FDA approval of LNTH-2501 radiopharma diagnostic kit

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Replimune to ask FDA for re‑review of melanoma drug, as agency stands by past rejections

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FDA Issues Complete Response Letter to Aquestive's Anaphylm Over Packaging and Human Factors Issues

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Sanofi calls FDA rejection of potential MS blockbuster tolebrutinib “unexpected” amid evolving agency views on benefit–risk

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FDA Rejects Sydnexis Myopia Drug for Kids; Chugai to Buy Renalys for $98M Upfront

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Xspray's Dasynoc Faces FDA Approval Delay Due to Contract Manufacturing Issues

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FDA Rejects PTC's Vatiquinone Application for Friedreich's Ataxia, Requests Further Studies

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