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.
Two Mintz attorneys say a CDRH Warning Letter to a medical device sponsor of clinical research and compassionate use protocols may be the first time t...
FDA approves GSKs Lynavoy (linerixibat), the first U.S.-authorized therapy specifically for cholestatic pruritus in patients with primary biliary chol...
Sarepta says it will submit to FDA by the end of April sNDAs to convert the accelerated approvals of its Amondys 45 and Vyondys 53 Duchenne muscular d...
