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Multiple Violations in Next Science Inspection

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FDA warns Jacksonville, FL-based Next Science that it is illegally manufacturing and distributing adulterated and misbranded medic...

FDA in Upheaval as Staff Layoffs Begin

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HHS begins terminating FDA employees, with many receiving email notifications in the early morning hours or being denied entrance ...

Apellis Files Empaveli sNDA in Rare Kidney Diseases

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FDA accepts for priority review an Apellis Pharmaceuticals supplemental NDA for Empaveli (pegcetacoplan) for treating two severe a...

RFK Jr. Upends His Promise to Enhance Transparency

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Despite HHS secretary Robert F. Kennedy, Jr.s promises to boost transparency at HHS and its health agencies, staff cuts now occurr...

Marks Firing Challenges RFK Jr.s Fitness for Office

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FDA Webview editor Jim Dickinson analyzes the firing of CBER director Peter Marks and finds it a challenge to HHS secretary and va...

Corcepts Relacorilant Shows Promise in Ovarian Cancer

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Corcept Therapeutics says data from its pivotal Phase 3 ROSELLA trial demonstrated that relacorilant in combination with nab-pacli...

Medtronic Recalls Aortic Root Cannulas

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Medtronic recalls its Aortic Root Cannulas due to risks presented by unexpected loose material in the male luer used in the device...

Smallpox/Mpox Vaccine OKd Despite CBER Turmoil

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FDA approves Bavarian Nordics freeze-dried formulation of Jynneos smallpox and mpox vaccine despite concerns over CBER director Pe...

Vanda Files NDA for Antipsychotic Drug

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Vanda Pharmaceuticals files an NDA for Bysanti (milsaperidone) for treating acute Bipolar I disorder and schizophrenia.

Imfinzi Wins Approval for Bladder Cancer

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FDA approves AstraZenecas Imfinzi (durvalumab) for treating adults with muscle invasive bladder cancer.