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- FDA reprimands Lundbeck Seattle Biopharmaceuticals for inflated claims on Vyepti migraine webpagesThe U.S. Food and Drug Administration issued an untitled letter to Lundbeck Seattle Biopharmaceuticals criticizing two promotional webpages about its migraine treatment Vyepti. The agency said the…
- FDA pauses public release of Complete Response Letters to limit litigation riskThe FDA announced it has temporarily halted the routine public posting of Complete Response Letters (CRLs), which are letters sent to drug sponsors when the agency does not approve a marketing appl…