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...
FDA approves a higher-dose version of Novo Nordisks blockbuster weight-loss drug Wegovy (semaglutide) injection.
Ultrarare disease sufferers and advocates stage a mock funeral at FDA headquarters to grieve the lack of approved treatments for conditions that they ...
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...
FDA warns Eatontown, NJ-based Avertix Medical about Quality System, Medical Device Reporting, and Correction and Removal violations in its production ...
FDA warns Indias Patcos Cosmetics that it is marketing adulterated over-the-counter drug products that have significant violations of CGMPs.
