FDA grants in part and denies in part an AdvantaPharma petition seeking specific requirements on ANDA holders for generic nintedanib.
FDA requires an updated safety warning for Parkinsons drug products containing carbidopa/levodopa due to their potential to cause vitamin B6 deficienc...
Pfizer and Valneva plan to submit a BLA for their investigational Lyme disease vaccine candidate based on data demonstrating more than 70% efficacy in...
A legal update from Wilson Sonsini Goodrich & Rosati addresses FDAs release earlier this month of a draft guidance clarifying the scope and eligibilit...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.
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 hosts a public meeting next month aimed at exploring ways to expand access to nonprescription medications.
