Fresenius Medical Care recalls its Stay-Safe Catheter Extension Sets and Stay-Safe/Luer Lock Adapters to correct their instructions for use to prevent...
FDA publishes a draft guidance on using patient performance status as eligibility criteria for cancer drug trials.
FDA publishes a draft guidance with recommendations for increasing cancer drug trial participant diversity by selecting appropriate laboratory values ...
FDA warns Cardinal Health it is distributing unapproved medical devices that also have a Quality System Regulation violation.
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.
FDA accepts for priority review a GSK supplemental BLA for Jemperli (dostarlimab) for combination use with standard-of-care chemotherapy (carboplatin ...
Boehringer Ingelheim suggests several modifications to an FDA draft guidance on key information and facilitating understanding in informed consent.
