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FDA refuses to file a Harmony Biosciences Wakix sNDA to treat excessive daytime sleepiness due to idiopathic hypersomnia.[ Price : $8.95]
A bipartisan coalition of 37 state Attorneys General call on FDA to take enforcement actions against online sellers of counterfeit...[ Price : $8.95]
FDA warns Indias Jagsonpal Pharmaceuticals about CGMP deviations and other violations in its manufacturing of active pharmaceutica...[ Price : $8.95]
FDA warns Indias Tyche Industries about CGMP deviations in its manufacturing of active pharmaceutical ingredients.[ Price : $8.95]
Harmed Americans for Reform in Medical Device Safety asks FDA to repost two safety communications and to analyze and post its find...[ Price : $8.95]
A Med Device Online guest column lists and analyzes FDAs top five data quality citation issues in 2024.[ Price : $8.95]
FDA approves a GSK BLA for Penmenvy (meningococcal Groups A, B, C, W, and Y vaccine) for preventing invasive meningococcal disease...[ Price : $8.95]
The Trump Administration fires hundreds of FDA probationary employees over the weekend as part of its efforts to trim government f...