A legal update from Wilson Sonsini Goodrich & Rosati addresses FDAs release earlier this month of a draft guidance clarifying the scope and eligibilit...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.
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...
FDA approves Bristol Myers Squibbs Opdivo (nivolumab) for use with doxorubicin, vinblastine, and dacarbazine for adult and pediatric patients 12 years...
FDA is announcing a 6/12 public hearing to gather input on its Commissioners National Priority Voucher Pilot Program.
