Filter1d
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 Supra1d
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 ...
CNET on MSN4d
Banned but Not Gone: Learn 9 of the Most Popular Foods Containing Red Dye No. 3
The state of California banned the Red No. 3 dye and three other food additives in 2023, which gave manufacturers until 2027 ...
Rolling Out12d
FDA bans red dye but 8 risky food colors remain legal
Discover what FDA's red dye ban means for your food safety. Learn which synthetic colors remain in your favorite foods and ...
Monthly Prescribing Reference8d
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.
GlobalData on MSN3d
Supernus wins FDA approval for Parkinson’s pump on fourth try
Supernus Pharmaceuticals has won US approval for its wearable pump Onapgo (apomorphine hydrochloride) to treat symptoms of ...
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 ...
JD Supra9d
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 ...