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News Wire / health

FDA Denies Approval For Stroke Drug

NBC News Radio New York 16d16d Impact 5
The FDA has denied approval for a drug from Grace Therapeutics intended to treat a rare and often fatal type of stroke. The New Jersey-based company faced rejection due to issues regarding chemistry, manufacturing, and controls. The decision follows regulatory concerns over the drug's production standards. No timeline for resubmission was provided. The injectable medication is produced by a company based in New Jersey. The company intends to resolve these specific issues and resubmit the application.

Topics

FDA stroke treatment drug approval

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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.”

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.”

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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