Arcutis asks FDA to restrict approvals of any ANDA citing its Zoryve psoriasis cream as the reference-listed drug.
FDA opens its eSTAR electronic submission template for voluntary use for certain PMA submissions.
CBER director Peter Marks outlines his Centers plans to speed gene therapy development, such as through FDA-encouraged harmonization of manufacturing ...
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Three medical device industry stakeholders raise multiple legal and regulatory concerns with an FDA draft guidance on choosing an appropriate predicat...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...
