FDA approves Pfizers Besponsa (inotuzumab ozogamicin) for an expanded indication treating pediatric patients with relapsed or refractory CD22-positiv...
CDER researchers describe lessons learned from the four-year Model-Informed Drug Development pilot program and plans for the programs future.
FDA approves a Lantheus Holdings supplemental NDA for an expanded use for ultrasound enhancing agent Definity (perflutren lipid microsphere) in pediat...
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...
