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.
FDA issues a draft guidance encouraging drug developers to adopt new approach methodologies as part of a broader effort to reduce reliance on animal t...
Minutes from two February MDUFA 6 negotiating sessions show areas of agreement between FDA and industry and topics for which further discussion is nee...
