FDA directs Takeda to add a Boxed Warning to the labeling for its Adzynma enzyme replacement therapy for congenital thrombotic thrombocytopenic purpura.
FDA commissioner nominee Heidi Overton pledges to accelerate drug development, strengthen regulatory oversight and preserve the agency's scientific independence during her Senate confirmation hearing.
FDA directs Takeda to add a Boxed Warning to the labeling for its Adzynma enzyme replacement therapy for congenital thrombotic thrombocytopenic purpura.
FDA commissioner nominee Heidi Overton pledges to accelerate drug development, strengthen regulatory oversight and preserve the agency's scientific independence during her Senate confirmation hearing.
FDA issues a draft guidance on premarket submissions for robotically-assisted surgical devices and announces a public workshop.
FDA approves Eli Lilly’s Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin injection for controlling high blood sugar in adults with Type 2 diabetes.
