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The FDA found that a Maryland company that made drospirenone and ethinyl estradiol kits did not adequately investigate a sterility failure and repeated fungal recoveries in areas used to manufacture sterile injectables
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At the clinical level, EDIT-101 is the first use of a genome editor in the CNS and is currently in phase 1/2 clinical trials in adult and pediatric patients ( Modified CRISPR activation Using the traditional CRISPR-Cas9 complex as a basis, a modified version in which the Cas9 enzyme is inactive or “dead” (dCas9) has been developed [64]
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