FDA approves Mercks Gardasil 9 (human papillomavirus (HPV) 9-valent vaccine, recombinant) for preventing oropharyngeal and other head and neck cancers...
FDA posts a question and answer Web page to address adverse event reporting for medical devices distributed under Emergency Use Authorizations.
A new FDA safety alert warns health care providers about a newly discovered potential drug interaction related to Gilead Sciences investigational anti...
FDA issues a Warning Letter to Eucyt Laboratories based on an inspection 11/2019 that cited the firms cell/tissue products for not having agency appro...
Eli Lilly enrolls the first patient in a Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of baricitinib...
Some 51 states and territories file a third complaint in Connecticut federal court alleging that 26 generic drug companies conspired to fix price on s...
An FDA grant and a philanthropic gift from Mei Xu, founder of e-commerce platform Yes She May, will fund a product development competition focused on ...
FDA approves a Viela Bio BLA for Uplizna (inebilizumab-cdon) injection for intravenous use for treating neuromyelitis optica spectrum disorder.