Ultrarare disease sufferers and advocates stage a mock funeral at FDA headquarters to grieve the lack of approved treatments for conditions that they ...
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...
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...
FDA approves a higher-dose version of Novo Nordisks blockbuster weight-loss drug Wegovy (semaglutide) injection.
FDA approves GSKs Lynavoy (linerixibat), the first U.S.-authorized therapy specifically for cholestatic pruritus in patients with primary biliary chol...
CSL notes it is actively working with regulatory authorities to address the shortage and develop strategies to ensure a stable long-term supply while ...
FDA approves a LivaNova PMA for its aura6000 System, a novel implantable device designed to treat adults with moderate to severe obstructive sleep apn...
