Several drug companies raise prices on some 250 drugs for 2020.
Mesoblast files as part of a rolling BLA clinical efficacy and safety data for remestemcel-L, indicated for treating children with steroid-refractory ...
FDA approves the expanded use of Amarins Vascepas (icosapent ethyl) to reduce the risk of cardiovascular events as an adjunct to statin therapy in adu...
Federal Register notice: FDA issues a final rule amending requirements for medical device premarket submissions to require a single submission in elec...
Federal Register: FDA makes available a draft guidance entitled FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology D...
FDA authorizes the de novo marketing of Tandem Diabetes Cares Control-IQ Technology, an interoperable automated glycemic controller device that adjust...
Federal Register notice: FDA issues a final rule to repeal a regulation that required an FDA-approved NDA or ANDA for any drug product that is sterili...
FDA clears a Boston Scientific 510(k) for its Exalt Model D Single-Use Duodenoscope.