FDA clears a Cutera 510(k) for AviClear, a laser treatment for mild, moderate, and severe acne.
Ongoing FDA concerns about PI3K inhibitors prompts the agency to discourage MEI Pharma and Kyowa Kirin from seeking accelerated approved of a BLA for ...
The House Oversight and Reform committee asks FDA for answers to what regulatory enforcement actions it sought against Medtronics troubled HeartWare V...
The Senate passes the Cannabidiol and Marijuana Research Expansion Act that is intended to ensure that research on cannabidiol and other potentially b...
FDA amends a GlaxoSmithKline and Vir Biotechnology Emergency Use Authorization for sotrovimab because the 500mg therapy is unlikely to be effective in...
FDA grants a second breakthrough designation to Pfizers respiratory syncytial virus vaccine candidate, this time to prevent lower respiratory tract di...
FDA approves a label update for Janssens Cabenuva to permit starting the injection treatment without an oral treatment lead-in.
FDA sends Eli Lilly and Innovent Biologics a complete response letter on its BLA for sintilimab injection, a me-too PD-1 inhibitor for treating certai...