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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...

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...

Covid Vaccine Nixed for Children/Pregnant Women

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HHS removes Covid-19 vaccine recommendations for healthy children and healthy pregnant women from CDCs recommended immunization sc...