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...
FDA grants a priority review to an Ionis Pharmaceuticals NDA for zilganersen, an experimental treatment for Alexander disease.
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.
Lilly says its investigational type 2 diabetes triple agonist retatrutide met its key primary and secondary endpoints in a Phase 3 trial.