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GSK Plans for Antibiotic NDA in 2nd Half

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GSK plans to submit an NDA in the second half of the year after it and Spero Therapeutics announced that they will end their Phase...

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...