Experts say two new guidances — issued without the usual public comment period — leave questions about how patients will ...
Americans who smoke may soon be hearing a lot more about Zyn. That's the flavored nicotine pouch that's generated billions in ...
An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...
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FDA Blood Pressure Med Recall-What to Know Right Now
Breaking news for people with high blood pressure: The Food and Drug Administration (FDA) just announced that over 580,000 bottles of blood pressure medications made by Teva Pharmaceuticals USA and ...
The U.S. Food and Drug Administration (FDA) has published its guidance agenda for Fiscal Year 2026, announcing plans for eight guidance documents to be released this upcoming year. It also named 12 ...
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As the FDA Removes the Black Box Warning Label From HRT Therapy, Folks Ask What It Means
The U.S. Food and Drug Administration has removed the black box warning labels from menopause hormone replacement therapy (HRT) products, and the move has folks asking why. The FDA announced the ...
Biologics are complex medications produced through biological processes or from living organisms such as proteins and genes. Biosimilars are what they sound like — similar to, but not the same as, an ...
Helen Branswell covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development. Follow her on Mastodon and Bluesky. You can reach Helen on ...
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