Three medical device industry stakeholders raise multiple legal and regulatory concerns with an FDA draft guidance on choosing an appropriate predicat...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 ...
A lengthy Bloomberg News article outlines concerns the Defense Department, health systems, and Congress have about FDAs ability to evaluate the safety...
Roche says it will discuss with FDA and other health authorities positive results from the Phase 3 INAVO120 study of inavolisib in combination with pa...
