LONG BEACH, California — Percutaneous coronary intervention procedures performed using the radial artery in the arm have almost tripled in the past decade, according to a […]
STOCKHOLM, Sweden — New data on clazakizumab, a monoclonal antibody targeting interleukin-6 (IL-6), and home hemodialysis suggest the potential of two ways to reduce the high […]
FROM ASCO 2024 Asciminib, a first-in-class tyrosine kinase inhibitor (TKI), shows efficacy and significantly improved tolerability compared with standard of care TKIs as a frontline treatment […]
TOPLINE: Isotretinoin was effective in treating acne in individuals undergoing masculinizing gender-affirming hormone therapy in a case series, but more information is needed on dosing and […]
On This Page Date: August 8, 2019 Time: 12:00 PM – 4:00 PM ET Co-sponsored by the:U.S. Food and Drug Administration (FDA) andthe Bladder Cancer Advocacy […]
Summary FDA has received reports of allergic-type reactions potentially related to sulfite-containing compounded drugs. FDA is alerting health care professionals, compounders and patients about the risk […]
CDER has established an Exclusivity Board to provide oversight and recommendations regarding exclusivity determinations made by the Center, with a primary focus on clarity and consistency […]
What We Do The Division of Applied Regulatory Science (DARS) moves new science into the FDA regulatory process and addresses emergent regulatory and public health questions. […]
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