The U.S. Food and Drug Administration approved Avlayah (tividenofusp alfa-eknm) to treat certain individuals with Hunter syndrome (Mucopolysaccharidosis type II or MPS II).   “Today…

As part of the U.S. Food and Drug Administration’s continuous quality improvement efforts, the agency today published a Federal Register Notice seeking public comment on…

The U.S. Food and Drug Administration today approved a new higher dose (7.2 mg) of Wegovy (semaglutide) injection, called Wegovy HD, for weight loss and…

The U.S. Food and Drug Administration today issued a draft guidance intended to help drug developers validate new approach methodologies (NAMs) to be used instead…

The U.S. Food and Drug Administration today launched a new unified platform for analyzing adverse event reports. This platform — called the FDA Adverse Event…

The U.S. Food and Drug Administration today approved expanded use of Wellcovorin (leucovorin calcium) tablets for the treatment of cerebral folate deficiency in adult and…

The U.S. Food and Drug Administration today announced another major step in its initiative to streamline the development of biosimilar medicines, which are like “generic”…

Earlier this week, the U.S. Food and Drug Administration held a meeting with several states to discuss the section 804 importation program (SIP), which allows…

The U.S. Food and Drug Administration today approved teclistamab in combination with daratumumab hyaluronidase-fihj, Tec-Dara, to treat adult patients with relapsed or refractory multiple myeloma…

The U.S. Food and Drug Administration today issued a Request for Information (RFI) seeking public comment on potential new standards for in-home opioid disposal products….