FDA accepts for priority review a Bristol Myers Squibb (BMS) supplemental BLA for Opdivo (nivolumab) for combination use with cisplatin-based chemothe...
Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions during July, August, and September.
Three medical device industry stakeholders raise multiple legal and regulatory concerns with an FDA draft guidance on choosing an appropriate predicat...
FDA warns Chicago, IL-based Belmont Eyecare it is illegally marketing six types of eye drops that are unapproved new drugs.
Lilly says that MONARCH 3 trial results indicate its Verzenio plus an aromatase inhibitor had a better survival rate than the control group at eight y...
A recent conference panel describes how FDA Product Jurisdiction Officers provide one-stop communication and coordination services for potential combi...
CDER researchers say their statistical analysis demonstrates that switching between biosimilars and their reference products is not associated with ma...
FDA accepts for priority review an ImmunoGen supplemental BLA to convert the accelerated approval of Elahere (mirvetuximab soravtansine-gynx) to full ...
