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- FDA uncages Aardvark’s Prader-Willi study after new data cleared safety concernsAfter cardiac safety signals led to a full clinical hold on Aardvark Therapeutics’ studies of ARD-101, the biotech conducted an additional safety study, in which no cardiac events were detected. Aa…BioSpace · 18d ago↗ source
- FDA uncages Aardvark’s Prader-Willi study after new data cleared safety concernsAfter cardiac safety signals led to a full clinical hold on Aardvark Therapeutics’ studies of ARD-101, the biotech conducted an additional safety study, in which no cardiac events were detected. Aa…BioSpace · 18d ago↗ source
- FDA approves GSK-Ionis antisense drug Hibsago, opening functional-cure market for hepatitis BThe U.S. Food and Drug Administration has granted approval to Hibsago (bepirovirsen), a partnership product of GSK and Ionis Pharmaceuticals, marking the first antisense oligonucleotide cleared for…