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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...[ Price : $8.95]
CDERs Accelerating Rare Disease Cures online newsletter says there were 26 orphan drug approvals in 2024 and lists four approvals ...[ Price : $8.95]
In a 5/27 podcast interview, HHS secretary Robert F. Kennedy Jr. continues his verbal assault against the pharmaceutical industry ...[ Price : $8.95]
Senator Dick Durbin (D-IL) asks FDA commissioner Marty Makary how CDERs Office of Prescription Drug Promotion can adequately regul...[ Price : $8.95]
To make FDA great again, FDA Webview editor James G. Dickinson urges Congress to impeach HHS secretary RFK Jr. on four counts of m...[ Price : $8.95]
FDA warns Fairfield, NJ-based AACE Pharmaceuticals about the lack of an adequate quality control unit for its drug manufacturing f...[ Price : $8.95]
FDA warns Madrid, Spain-based Sedecal about Quality System violations in its production of mobile digital radiography systems.[ Price : $8.95]
After issuing a safety alert in April, FDA follows up with a Warning Letter to Kabe Labortechnik, the German manufacturer of the R...