Alvotech HF – 09/17/2024

FDA-TRACK: Biosimilar User Fee Act Procedural Response Goals Summary

The list is updated quarterly. Changes are made to the DMF activity status, DMF type, holder name, and subject.

Innovative drugs often mean new treatment options for patients and advances in health care for the American public.

Consumer articles about over-the-counter and prescription drugs.

CDER’s work with foreign stakeholders enables progress in the harmonization of scientific and technical standards and regulatory requirements among regulatory authorities.

The U.S. Food and Drug Administration (FDA) approved Myqorzo (aficamten) tablets to treat adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms.