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...
The International Council for Harmonization Assembly approves the addition of three new topics for harmonization.
FDA has extended by three months an ARS Pharmaceuticals NDA for neffy (intranasal epinephrine) for treating allergic reactions, including anaphylaxis.
FDA approves Surmodics SurVeil drug-coated balloon and its use in percutaneous transluminal angioplasty.
