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FDA clears a Curio Digital Therapeutics 510(k) for its MamaLift Plus, a prescription digital therapeutic for treating postpartum d...[ Price : $8.95]
An FDA inspection at Zydus Lifesciences injectable manufacturing site in Jarod, India results in a 10-observation Form FDA-483, th...[ 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]
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Boehringer Ingelheim suggests several modifications to an FDA draft guidance on key information and facilitating understanding in ...[ Price : $8.95]
FDA publishes a draft guidance with questions and answers on promotional communications for some prescription biologics.[ Price : $8.95]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...