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Former McKinsey Partner Sentenced for Purdue Work

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Former McKinsey & Company senior partner Martin Elling is sentenced to six months in federal prison, supervised release after inca...

Promising Trial Results for Wegovy Add-on: Veru

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Veru announces positive topline results from its Phase 2b QUALITY clinical trial that is evaluating enobosarm when added to semagl...

Mitsubishi Tanabe Resubmits NDA for Parkinsons Combo

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FDA accepts for review a Mitsubishi Tanabe Pharma America NDA resubmission for investigational ND0612, a continuous, subcutaneous ...

Zhejiang Huahai FDA-483 Released

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FDA releases the form FDA-483 with seven observations from a January inspection at Chinas Zhejiang Huahai Pharmaceuticals.

To Make FDA Great Again, Impeach RFK Jr.

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To make FDA great again, FDA Webview editor James G. Dickinson urges Congress to impeach HHS secretary RFK Jr. on four counts of m...

Inspection Issue at AACE Pharmaceuticals

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FDA warns Fairfield, NJ-based AACE Pharmaceuticals about the lack of an adequate quality control unit for its drug manufacturing f...

Quality System Issues in Spains Sedecal Inspection

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FDA warns Madrid, Spain-based Sedecal about Quality System violations in its production of mobile digital radiography systems.

Warning Letter to Kabe Follows Recent Safety Alert

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After issuing a safety alert in April, FDA follows up with a Warning Letter to Kabe Labortechnik, the German manufacturer of the R...

Congress Should End Government Layoffs: Professor

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Harvard University health policy professor Benjamin Sommers calls on Congress to stand up against cuts in the federal workforce th...

Prothena Scraps Birtamimab After Phase 3 Miss

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Prothena discontinues the development of birtamimab, its investigational treatment for AL amyloidosis, after the drug failed to me...