FDA Rejects Stroke Treatment Application
The FDA has denied approval for a therapeutic injectable drug designed to treat strokes caused by ruptured brain aneurysms. The agency cited concerns regarding the chemistry, manufacturing, and controls of the medication produced by a New Jersey-based company. The manufacturer intends to resolve the identified issues and resubmit its application for approval. The drug is intended for a rare but often deadly type of stroke. The pharmaceutical company involved plans to resolve the specific issues raised by regulators.
Topics
Developing
- 892d Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore.
- 892d Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur.
- 892d Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est.
- 892d Sed ut perspiciatis unde omnis iste natus error sit voluptatem accusantium doloremque laudantium.
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.”
NBC News Radio
“The agency says it has issues with the chemistry, manufacturing and controls of the New Jersey based companies stroke drug.”
NBC News Radio
“The company plans to resolve the issues raised and resubmit its application.”
Unlock the full story
Get a Pro subscription or above to see the live story progression and the full list of independent sources confirming each event as they happen.
Log in to upgrade