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Guidance on Aluminum Content in Parenteral Drugs

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FDA issues a draft guidance entitled Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Al...

FDA Elsa Rollout a Nuanced Dance: Consultant

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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...

Sirtex Medical Wins Device OK for Liver Cancer

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

Vacate RFK Jr. Covid Vaccine Recommendations: Lawsuit

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

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.