FDA Related News

FDA General

FDA Elsa Rollout a Nuanced Dance: Consultant

Consultant Erika Roberts says FDAs rollout of its staff AI tool Elsa is a good first step, but much more needs to be done to reach the potential of us...

Medical Devices

Sirtex Medical Wins Device OK for Liver Cancer

FDA approves a Sirtex Medical PMA for its SIR-Spheres Y-90 resin microspheres for treating unresectable hepatocellular carcinoma.

Biologics

Vacate RFK Jr. Covid Vaccine Recommendations: Lawsuit

A group of medical societies files suit against HHS secretary Robert F. Kennedy Jr. and FDA commissioner Marty Makary to reverse a 5/27 decision to re...

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.