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Members of an FDA advisory committee unanimously recommended Merck’s anesthesia candidate sugammadex for approval, a win for the drug giant, which saw the candidate previously held back over safety and data integrity concerns. Read More
FDA reviewers will revisit Merck’s anesthesia drug sugammadex this week in its fourth review attempt, taking on safety concerns that originally tripped up the candidate in 2008. Read More
The moment dietary supplement manufacturers start making specific curative claims, supplements are seen as drugs in the eyes of the FDA and require an IND, says a new guidance document. Read More