A new study published in JAMA Network Open highlights growing public health concerns over prescription drug promotion by social media influencers.
The International Council for Harmonization outlines a roadmap for future global standards on advanced drug manufacturing, highlighting gaps in curren...
FDA requires an updated safety warning for Parkinsons drug products containing carbidopa/levodopa due to their potential to cause vitamin B6 deficienc...
A legal update from Wilson Sonsini Goodrich & Rosati addresses FDAs release earlier this month of a draft guidance clarifying the scope and eligibilit...
FDA grants a priority review to an Ionis Pharmaceuticals NDA for zilganersen, an experimental treatment for Alexander disease.
Pfizer and Valneva plan to submit a BLA for their investigational Lyme disease vaccine candidate based on data demonstrating more than 70% efficacy in...
FDA hosts a public meeting next month aimed at exploring ways to expand access to nonprescription medications.
U.S. Senator Rick Scott (R-FL) urges FDA and other federal health agencies to review and tighten oversight of clinical trials and drug approvals invol...
