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CDER researchers describe lessons learned from the four-year Model-Informed Drug Development pilot program and plans for the progr...[ Price : $8.95]
FDA approves a Lantheus Holdings supplemental NDA for an expanded use for ultrasound enhancing agent Definity (perflutren lipid mi...[ Price : $8.95]
FDA grants Quanterix a breakthrough device designation for its Simoa phospho-Tau 217 blood test as an aid in diagnostically evalua...[ Price : $8.95]
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.