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Similarly, Section 503B does not allow for compounding of drugs that are essentially a copy of one or more approved drugs but the statute notes that this does not apply to drugs on the drug shortage list in effect under Section 506E. The 506E shortage list recognizes drugs that have low availability due to manufacturing or quality problems, delays or discontinuations
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These readouts, expected between late 20252026, could redefine the drugs commercial trajectorywith management indicating that two of three positive outcomes may secure regulatory approval
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