FDA clears a Curio Digital Therapeutics 510(k) for its MamaLift Plus, a prescription digital therapeutic for treating postpartum depression.
An FDA inspection at Zydus Lifesciences injectable manufacturing site in Jarod, India results in a 10-observation Form FDA-483, the second received by...
Dr. Reddys Laboratories recalls six lots of sapropterin dihydrochloride powder for oral solution 100 mg due to decreased potency.
FDA approves Utility Therapeutics Pivya for some uncomplicated urinary tract infections.
Boehringer Ingelheim suggests several modifications to an FDA draft guidance on key information and facilitating understanding in informed consent.
FDA publishes a draft guidance with questions and answers on promotional communications for some prescription biologics.
The educational group Healthy Women petitions FDA to change fenofibrate labeling to state there is no proven cardiovascular benefit to using fenofibra...
FDA accepts for priority review a GSK supplemental BLA for Jemperli (dostarlimab) for combination use with standard-of-care chemotherapy (carboplatin ...
