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Three medical device industry stakeholders raise multiple legal and regulatory concerns with an FDA draft guidance on choosing an appropriate predicat...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...
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...
