Executive SummaryJust how inefficient is the US health care system? Not at all, compared to Japan. A comparison between the two countries underscores less one system’s strength or weakness than fundamental differences between the two: Japan’s is a system in which drug treatment is far preferred to surgical intervention.
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Sarepta’s Vyondys: Renal Toxicity Concerns That Delayed Approval Get Enhanced Postmarketing Scrutiny, Label Warning
Sarepta must perform enhanced pharmacovigilance for serious renal toxicity events and rhabdomyolysis with the Duchenne muscular dystrophy drug, which carries a label warning for renal toxicity. Approval letter includes 2024 target completion date for ESSENCE confirmatory trial.