FDA Denies Approval For Stroke Drug
The FDA has denied approval for a Grace Therapeutics drug designed to treat strokes caused by ruptured brain aneurysms. The New Jersey-based company faces regulatory issues regarding the chemistry, manufacturing, and controls of the injectable medication. Grace Therapeutics plans to resolve the specific issues raised by the agency. The drug was intended to treat a rare but often deadly type of stroke.
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Sources · 7 independent
NBC News Radio
“The FDA is denying approval for a grace therapeutics drug intended to treat a rare but often deadly type of stroke. The agency says it has issues with the chemistry, manufacturing and controls of the New Jersey based companies stroke drug.”
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