FDA approves a Boston Scientific PMA for the LOTUS Edge Aortic Valve System.
The NIH works with FDA to modify government oversight of gene therapy.
FDA publishes a guidance on the content and f.ormat of non-clinical bench performance testing information in premarket submissions.
FDA releases a final guidance on Unique Device Identification: Convenience Kits.
Gilead Sciences says its Phase 3 STELLAR-3 study, which evaluated selonsertib in patients with bridging fibrosis due to nonalcoholic steatohepatitis, ...
FDA approves an Ortho Dermatologics NDA for Duobrii (halobetasol propionate and tazarotene) lotion, 0.01%/0.045%, indicated for the topical treatment ...
The Justice Department says Astellas and Amgen will pay a total of $124.75 million to resolve charge that they paid illegal kickbacks to patients to u...
Eli Lilly says it is withdrawing rare cancer drug Lartruvo (olaratumab) from the market based on data from a confirmatory trial in which the drug did ...