Filter2d
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 Supra2d
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 ...
Rolling Out13d
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 ...
Magnolia Reporter1h
U.S. food, drug makers have 2 to 3 years to remove banned Red No. 3 from products
The Food and Drug Administration has revoked use of the synthetic dye Red No. 3 — approved to provide color in food and drugs ...
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 ...
Monthly Prescribing Reference9d
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.
ScienceAlert13d
Expert Reveals Why The FDA Finally Banned 'Red 3' Dye
However, mounting scientific evidence suggests that consuming Red 3 poses significant health risks. These risks prompted ...
Moscow-Pullman Daily News8d
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 ...
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 Supra10d
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 ...