Federal Register notice: FDA provides notice that is has received a copy of a patent infringement complaint that had been filed against a pending bios...
FDA clears an Abbott 510(k) for its FreeStyle Libre 2 and FreeStyle Libre 3 integrated continuous glucose monitoring system sensors for integration wi...
CDER director Patrizia Cavazzoni says the agency is stepping up its actions to prevent contaminated drug products, including cough/cold syrups with di...
Presumably in an attempt to block or delay potential generic Mayzent products, Novartis petitions FDA to make generic versions meet certain requiremen...
FDA accepts for priority review an Eisai and Biogen supplemental BLA for Leqembi (lecanemab-irmb) 100 mg/mL injection that is intended to convert the ...
Lawyers from Troutman Pepper say that two recent medical product cases could be a harbinger of more Department of Justice deferred prosecution agreeme...
FDA announces a 4/12 Nonprescription Drugs Advisory Committee meeting to discuss the adequacy of efficacy data available for over-the-counter use of o...
Exelixis says its Phase 3 CONTACT-03 study evaluating the companys Cabometyx (cabozantinib) in combination with atezolizumab versus cabozantinib alone...
