FDA grants full approval to Amgens previously accelerated-approved BLA for Blincyto (blinatumomab) for treating certain adults and pediatric patients ...
FDA launches a pilot program to post laboratory-developed test performance information using biomarkers to help facilitate better cancer drug selectio...
FDA issues F2G Ltd. a complete response letter on its NDA for olorofim, an antifungal for invasive fungal infections in patients who have limited or n...
FDA warns Tustin, CA-based Vitang Technology that its UniSmile Dental Aligner is misbranded and adulterated and thus is being sold illegally.
FDA issues a clinical hold on Arcellxs CART-ddBCMA for treating patients with relapsed or refractory multiple myeloma, after a recent patient death wa...
Federal Register notice: FDA announces an 8/22-23 advisory committee meeting to review a ReCor PMA and a Medtronic PMA for their devices to treat hype...
University of Pennsylvania medical school professor Jason Karlawish makes the case for FDA to require a detailed REMS for new Alzheimers disease drugs...
FDA explains its reasoning for granting in part and denying in part a Boehringer Ingelheim 2012 petition concerning its Spiriva Handihaler and other t...
