FDA grants Quanterix a breakthrough device designation for its Simoa phospho-Tau 217 blood test as an aid in diagnostically evaluating Alzheimers Dise...
Federal Register notice: FDA makes available its decision to deny a request for a hearing on a CDER-proposed decision to not approve a Vanda Pharmaceu...
Federal Register notice: FDA sends to OMB an information collection revision entitled Applications for FDA Approval To Market a New Drug 21 CFR Part ...
Smiths Medical ASD recalls its Medfusion model 3500 syringe pump due to software-related issues that can cause the device to fail to deliver therapy.
Novo Nordisk says it will file a supplemental NDA this year seeking an expanded label for Ozempic (semaglutide) for preventing progression of kidney i...
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...
