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FDA reviewers expressed strong concerns over the possibility of liver damage related to solithromycin treatment ahead of an advisory committee meeting Friday on whether the drug should be approved as an antibiotic for community-acquired bacterial pneumonia. Read More
Working groups representing both the generic and brand-name pharmaceutical industries told the FDA they need more guidance on how generic versions of abuse-deterrent opioid medications will be reviewed and approved. Read More
An FDA advisory committee voted to recommend approving a formulation of desmopressin for frequent nighttime urination, with some saying it should be approved in a separate indication that had not been explicitly tested in a clinical trial. Read More