FDA Related News

Medical Devices

Multiple Insightra Medical Violations Cited

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

Human Drugs

FDA Study Finds Liver Risks Associated with CBD

A new FDA clinical trial finds that cannabidiol may cause liver enzyme elevations in otherwise healthy adults raising new concerns about the safety o...

Medical Devices

Expanded Parkinsons Use OKd for Insightec Device

FDA approves an expanded indication for Insightecs Exablate Neuro platform for staged bilateral pallidothalamic tractotomy treatment in patients livin...

Human Drugs

FDA Oxylanthanum Carbonate Complete Response Letter

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

Human Drugs

FDA Accelerated Approval for Dizal Zegfrovy

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

Human Drugs

Staska Multiple Outsourcing Facility Violations

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

Medical Devices

Abiomed Pump Controller Needs Update: FDA

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

Human Drugs

Delayed Hereditary Angioedema Drug Wins Approval

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

Human Drugs

FDA Priority Review for Hunter Syndrome Therapy

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

FDA Inspectors Say Conditions Still Hard

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