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These filings also raise broader questions about whether labeling and risk disclosures adequately addressed the potential for serious complications associated with delayed gastric emptying and impaired intestinal motility

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This complicates genotype-to-phenotype correlations, as it is difficult to infer which mutation is primarily responsible for deficient enzyme function and the clinical phenotype

"FDA created this system because these are necessary drugs." Novo Nordisk hasn't specified why it can't keep up with demand, but the bottleneck apparently lies in the company's inability to fill and sterilize enough of its special drug auto-injectors, said Evan Seigerman, a managing director at BMO Capital Markets

An infant may be diagnosed during standard newborn screening tests

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