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Multiple Insightra Medical Violations Cited

[ Price : $8.95]

FDA warns Clarksville, TN-based Insightra Medical about multiple violations in its production of intra-aortic balloon pump cathete...

FDA Study Finds Liver Risks Associated with CBD

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A new FDA clinical trial finds that cannabidiol may cause liver enzyme elevations in otherwise healthy adults raising new concern...

Expanded Parkinsons Use OKd for Insightec Device

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FDA approves an expanded indication for Insightecs Exablate Neuro platform for staged bilateral pallidothalamic tractotomy treatme...

FDA Oxylanthanum Carbonate Complete Response Letter

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FDA issues a complete response letter to Unicycive Therapeutics for its hyperphosphatemia drug oxylanthanum carbonate that cites i...

FDA Accelerated Approval for Dizal Zegfrovy

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FDA gives accelerated approval to Dizals lung cancer drug Zegfrovy, along with a companion diagnostic device.

Staska Multiple Outsourcing Facility Violations

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FDA warns Staska Pharmaceuticals, a Bennett, NE, outsourcing facility, about its multiple failures to meet requirements for such f...

Abiomed Pump Controller Needs Update: FDA

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FDA issues an Early Alert for an Abiomed Automated Impella Controller issue that has resulted in three deaths.

Delayed Hereditary Angioedema Drug Wins Approval

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After delaying a review action last month, FDA now approves a KalVista Pharmaceuticals NDA for Ekterly (sebetralstat) for treating...

FDA Priority Review for Hunter Syndrome Therapy

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FDA accepts for priority review a Denali Therapeutics BLA for tividenofusp alfa for treating Hunter syndrome.

FDA Inspectors Say Conditions Still Hard

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A ProPublica investigative report says FDA inspectors continue to have issues arising from the dismissal of many of their support ...