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FDA Approves Drug to Treat Neurologic Manifestations of Hunter Syndrome
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).
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FDA Schedules Public Meeting on the Commissionerβs National Priority Voucher Pilot Program
As part of the U.S. Food and Drug Administrationβs continuous quality improvement efforts, the agency today published a Federal Register Notice seeking public comment on the Commissionerβs National Priority Voucher pilot program.
FDA Approves Fourth Product Under National Priority Voucher Program, Higher Dose Semaglutide
The U.S. Food and Drug Administration today approved a new higher dose (7.2 mg) of Wegovy (semaglutide) injection for weight loss and long-term maintenance of weight loss for certain adult patients.
FDA Releases Draft Guidance on Alternatives to Animal Testing in Drug Development
The U.S. Food and Drug Administration today issued draft guidance intended to help drug developers validate new approach methodologies (NAMs) to be used instead of animal testing in drug development, and to bring safe, effective drugs to market sooner based on human-centric data.
