US Drug Approval Denied for Stroke Treatment
The FDA has denied approval for a New Jersey-based company's injectable medication designed to treat strokes caused by ruptured brain aneurysms. The agency cited issues with the drug's chemistry, manufacturing, and controls. This denial comes after previous research indicated the drug could prevent sudden cardiac death.
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Sources · 7 independent
NBC News Radio
“The FDA is denying approval for a grace therapeutic 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. The injectable medication is designed to treat strokes caused by a ruptured brain aneurysm.”
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