FDA commissioner nominee Heidi Overton pledges to accelerate drug development, strengthen regulatory oversight and preserve the agency's scientific in...
FDA issues a draft guidance on premarket submissions for robotically-assisted surgical devices and announces a public workshop.
FDA approves Eli Lillys Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin injection for controlling high blood sugar in adults with Typ...
FDA approves a combination of Mercks Welireg and Eisais Lenvima to treat some patients with renal cell carcinoma with a clear cell component.
FDA directs Takeda to add a Boxed Warning to the labeling for its Adzynma enzyme replacement therapy for congenital thrombotic thrombocytopenic purpur...
FDA releases the Form FDA-483 with three observations from its inspection at the Columbus, OH-based STAQ Pharma Ohio outsourcing facility.
CBER issues a Standard Operating Policy and Procedure on scheduling and conducting regulatory meetings on drugs and biologics.
A federal court has entered a consent decree of permanent injunction against Gold Star Distribution, Inc., prohibiting the Minnesota warehouse operato...
