FDA approves Sandoz Jubbonti and Wyost, the first interchangeable biosimilars for Amgens Prolia and Xgeva.
Senate and House appropriators post a joint spending bill agreement for fiscal year 2024 that would provide FDA with a $160 million (2.4%) budget boos...
FDA clears a Dexcom 510(k) for the companys Stelo Glucose Biosensor System, which the agency says is the first over-the-counter continuous glucose mon...
Federal Register notice: FDA sends to OMB an information collection extension entitled Data to Support Drug Product Communications as Used by the Food...
FDA approves a Boston Scientific PMA for the AGENT Drug-Coated Balloon (DCB), indicated for treating coronary in-stent restenosis in patients with cor...
FDA affirms its regulation of fresh allograft heart valves in a just-posted letter to healthcare professionals.
FDA extends by three months its review on a Zevra Therapeutics NDA resubmission for arimoclomol, an investigational oral treatment for Niemann-Pick di...
FDA approves Hugels Letybo (botulinum toxin), a neurotoxin for treating moderate-to-severe glabellar (frown) lines in adults.
