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Three medical device industry stakeholders raise multiple legal and regulatory concerns with an FDA draft guidance on choosing an ...[ Price : $8.95]
FDA warns Chicago, IL-based Belmont Eyecare it is illegally marketing six types of eye drops that are unapproved new drugs.[ Price : $8.95]
Lilly says that MONARCH 3 trial results indicate its Verzenio plus an aromatase inhibitor had a better survival rate than the cont...[ Price : $8.95]
A recent conference panel describes how FDA Product Jurisdiction Officers provide one-stop communication and coordination services...[ Price : $8.95]
CDER researchers say their statistical analysis demonstrates that switching between biosimilars and their reference products is no...[ Price : $8.95]
FDA accepts for priority review an ImmunoGen supplemental BLA to convert the accelerated approval of Elahere (mirvetuximab soravta...[ Price : $8.95]
A lengthy Bloomberg News article outlines concerns the Defense Department, health systems, and Congress have about FDAs ability to...[ Price : $8.95]
Roche says it will discuss with FDA and other health authorities positive results from the Phase 3 INAVO120 study of inavolisib in...