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26 FDA Orphan Drug Approvals in 2024

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CDERs Accelerating Rare Disease Cures online newsletter says there were 26 orphan drug approvals in 2024 and lists four approvals ...

RFK Jr. Attacks Corrupt Drug Firms and DTC Ads

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In a 5/27 podcast interview, HHS secretary Robert F. Kennedy Jr. continues his verbal assault against the pharmaceutical industry ...

Sen. Durbin Queries FDA on Drug Promo Staff Cuts

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Senator Dick Durbin (D-IL) asks FDA commissioner Marty Makary how CDERs Office of Prescription Drug Promotion can adequately regul...

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.