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Three medical device industry stakeholders raise multiple legal and regulatory concerns with an FDA draft guidance on choosing an appropriate predicat...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 extends by three months its review of an Optinose supplemental NDA for Xhance (fluticasone propionate) as a treatment for chronic rhinosinusitis.
FDAs Oncology Center of Excellence and real-world evidence company Syapse renew a four-year agreement to collaboratively develop and implement specifi...