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FDA Approves Tocilizumab Biosimilar Avtozma
The Food and Drug Administration (FDA) has approved Avtozma ® (tocilizumab-anoh), a biosimilar to Actemra ® (tocilizumab), in both intravenous (IV) and subcutaneous (SC) formulations.
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FDA’s Authorization of Zyn Nicotine Pouches a Step in the Right Direction
The groundbreaking decision is a win for harm reduction, though it also highlights absurd contradictions in the FDA's overall ...
JD Supra4d
Finally, FDA’s Final Word on Unapproved Use Communications
On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms ...
Moscow-Pullman Daily News11d
The story of food additives and banning of Red Dye No. 3
You may have heard in the news that the U.S. Food and Drug Administration will no longer allow the use of FD&C Red Dye No. 3 ...
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Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies
The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval ...
Insurer Denies Access To Drugs Granted Accelerated Approval By FDA
Going forward, we may see more instances in which insurers deny or (temporarily) severely restrict coverage of accelerated ...