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CBER director Peter Marks outlines his Centers plans to speed gene therapy development, such as through FDA-encouraged harmonizati...[ Price : $8.95]
FDA accepts for priority review a Bristol Myers Squibb (BMS) supplemental BLA for Opdivo (nivolumab) for combination use with cisp...[ Price : $8.95]
Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions during July, August, and Se...[ Price : $8.95]
Three medical device industry stakeholders raise multiple legal and regulatory concerns with an FDA draft guidance on choosing an ...[ Price : $8.95]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...