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Amneal Recalls 4 Lots of Vancomycin

[ Price : $8.95]

FDA says Amneal is recalling four lots of vancomycin HCl for oral solution because some of the bottles were over-filled during the...

Eugia Recalls Methocarbamol Injection Lot

[ Price : $8.95]

Eugia U.S. recalls one lot of methocarbamol injection due to a customer product complaint about the presence of white particles fl...

FDA OKs Expanded Use for Hepatitis B Drug

[ Price : $8.95]

FDA approves a Gilead Sciences supplemental NDA for Vemlidy (tenofovir alafenamide) 25 mg tablets as a once-daily treatment for ch...

Synaptive Medical Fluorescence Module Cleared

[ Price : $8.95]

FDA clears a Synaptive Medical 510(k) for its near-infrared fluorescence visualization module, Modus IR, adding to the existing fl...

Medexus Hemophilia B Factor Gets Expanded Use

[ Price : $8.95]

FDA approves a Medexus Pharmaceuticals supplemental BLA for Ixinity [coagulation factor IX (recombinant)] for treating pediatric p...

FDA Withdraws 30 No-Longer-Marketed ANDAs

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Federal Register notice: FDA withdraws approval of 30 abbreviated new drug applications from multiple applicants because the drug ...

OTC Monograph Drug User Fees

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Federal Register notice: FDA announces the over-the-counter Monograph Drug User Fee Program facility fee rates for fiscal year 202...

Weiner Moves to Foreign Inspections Office

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FDA Office of Combination Products associate director for policy John Weiner moves to Office of Global Operations director, where ...

Boston Scientific Recalls PolarSheath Steerable

[ Price : $8.95]

Boston Scientific recalls the PolarSheath Steerable Sheath 12F after the company identified a tooling error in manufacturing which...

Magnetic Stimulation for Adolescent Depression Cleared

[ Price : $8.95]

FDA clears a Neuronetics 510(k) for its NeuroStar Advanced Therapy for use as an adjunct for treating major depressive disorder in...