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FDA approves Utility Therapeutics Pivya for some uncomplicated urinary tract infections.[ 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]
Boehringer Ingelheim suggests several modifications to an FDA draft guidance on key information and facilitating understanding in ...[ Price : $8.95]
FDA publishes a draft guidance with questions and answers on promotional communications for some prescription biologics.[ Price : $8.95]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 warns Royal Philips about Quality System and Medical Device Reporting violations at its medical device manufacturing facility ...[ Price : $8.95]
Federal Register notice: FDA makes available its annual report entitled Report on the Performance of Drug and Biologics Firms in C...[ Price : $8.95]
Federal Register notice: An FDA advisory committee schedules a 5/23 meeting to review a Guardant Health PMA for its Shield blood t...