FDA proposes to add one active ingredient to the bulk drug substance list for drug compounding and proposes not to add four other substances.
The Justice Department says Fresenius Kabi Oncology was ordered to pay $50 million in fines and forfeitures after pleading guilty to failing to provid...
FDA principal deputy commissioner and acting chief information officer Amy Abernethy announces she will be leaving the agency in the next few weeks.
FDA clears a Recovery Force 510(k) for the Movement and Compressions System, a data-driven mobility measurement device designed for hospital and home ...
FDA gives Cybrexa Therapeutics the green light to begin a clinical trial for solid tumor therapy CBX-12 (alphalex-exatecan).
An FDA advisory committee briefing document says a Pfizer BLA for osteoarthritis drug tanezumab subcutaneous injection shows (XXX SUBSTITUTE XXX) a mo...
AstraZeneca interim data show that its Covid-19 vaccine efficacy 79% at preventing symptomatic Covid-19 and 100% efficacy at preventing severe disease...
FDA sends Warning Letters to two companies for selling OTC products labeled as containing cannabidiol.