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Federal Register notice: FDA makes available its decision to deny a request for a hearing on a CDER-proposed decision to not appro...[ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection revision entitled Applications for FDA Approval To Market a Ne...[ Price : $8.95]
Smiths Medical ASD recalls its Medfusion model 3500 syringe pump due to software-related issues that can cause the device to fail ...[ Price : $8.95]
Novo Nordisk says it will file a supplemental NDA this year seeking an expanded label for Ozempic (semaglutide) for preventing pro...[ Price : $8.95]
FDA approves Sandoz Jubbonti and Wyost, the first interchangeable biosimilars for Amgens Prolia and Xgeva.[ Price : $8.95]
Senate and House appropriators post a joint spending bill agreement for fiscal year 2024 that would provide FDA with a $160 millio...[ Price : $8.95]
FDA clears a Dexcom 510(k) for the companys Stelo Glucose Biosensor System, which the agency says is the first over-the-counter co...[ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension entitled Data to Support Drug Product Communications...