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FDA warns Cardinal Health it is distributing unapproved medical devices that also have a Quality System Regulation violation.[ Price : $8.95]
FDA accepts for priority review a GSK supplemental BLA for Jemperli (dostarlimab) for combination use with standard-of-care chemot...[ Price : $8.95]
Dr. Reddys Laboratories recalls six lots of sapropterin dihydrochloride powder for oral solution 100 mg due to decreased potency. ...[ Price : $8.95]
FDA approves Utility Therapeutics Pivya for some uncomplicated urinary tract infections.[ Price : $8.95]
Boehringer Ingelheim suggests several modifications to an FDA draft guidance on key information and facilitating understanding in ...[ Price : $8.95]
FDA publishes a draft guidance with questions and answers on promotional communications for some prescription biologics.[ Price : $8.95]
The educational group Healthy Women petitions FDA to change fenofibrate labeling to state there is no proven cardiovascular benefi...[ Price : $8.95]
FDA approves an Amneal Pharmaceuticals ANDA for a generic over-the-counter naloxone hydrochloride nasal spray, 4mg, (generic Narca...