FDAs Endocrinologic and Metabolic Drugs Advisory Committee votes 19 to 0 against approving Intarcia Therapeutics implantable ITCA 650 (exenatide in DU...
FDA publishes a draft guidance with recommendations about formal meetings between FDA and sponsors or applicants relating to drugs regulated by CDER a...
FDA publishes a draft guidance on how it will use alternative tools to assess manufacturing facilities named in NDAs, ANDAs, BLAs, and their supplemen...
Travere Therapeutics says confirmatory trial data for accelerated approval therapy Filspari (sparsentan) will form the basis of a sNDA next year that ...
Three Hogan Lovells attorneys analyze a recent FDA guidance on using the ISO 10993-1 international standard for medical device biocompatibility.
An NPR report says FDA has received nearly 500 complaints about mental health issues patients associate with using semaglutide drugs such as Ozempic.
FDA accepts for priority review a Merck supplemental BLA for Keytruda (pembrolizumab) and its combination use with external beam radiotherapy plus con...
FDA grants orphan drug designation to Puma Biotechnologys small cell lung cancer investigative drug aliserib.
