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FDA Approval Prescription Drugs Public Health

Goodwin

FDA Approves Expanded Indication for Celltrion’s AVTOZMA for the Treatment of Cytokine Release Syndrome

Goodwin on

On August 7, 2025, Celltrion announced that it obtained FDA approval expanding the indication of the intravenous (IV) formulation of AVTOZMA (tocilizumab-anoh) to include treatment of cytokine release syndrome (CRS) in...more

Holland & Knight LLP

Holland & Knight Health Dose: October 4, 2022

Holland & Knight LLP on

Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. This week's topics include... ...more

Knobbe Martens

U.S. FDA Approves Monkeypox Treatment Formulation

Knobbe Martens on

(May 25, 2022) SIGA Technologies Inc., a New York-based pharmaceutical company, has received approval from the U.S. Food and Drug Administration (FDA) for an intravenous formulation of TPOXX (tecovirimat) for the treatment of...more

Mintz - Health Care Viewpoints

Senators to Receive Update on Biosimilar Implementation from CDER’s Woodcock

On September 17, 2015, members of the Senate Health, Education, Labor & Pensions (HELP) Committee will have an opportunity to hear from and question Dr. Janet Woodock, the director of FDA’s Center for Drug Evaluation and...more

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