Trump order signals shake-up in drug pricing innovation through Medicare and Medicaid
President Donald Trump’s Day One executive order rescinding Biden-era Medicare and Medicaid price innovation programs signals ...
FDA approves Ozempic to reduce risks from chronic kidney disease in diabetes patients
Ozempic, the blockbuster GLP-1 drug that was originally approved to treat type 2 diabetes, has now also been approved by the ...
US FDA approves Novo Nordisk's Ozempic to cut risk of diabetic kidney disease progression
The U.S. FDA has approved Novo Nordisk's Ozempic for reducing the risk of kidney failure and disease progression, as well as ...
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FDA bans red dye No. 3 from food, drinks and ingested drugs in the US
Red dye No. 3 has been permissible for use in food despite the Delaney Clause of the FDA’s Federal Food, Drug, and Cosmetic ...
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FDA Wraps Up 2024 Handing Out Several Notable Regulatory Decisions
For many people, the end of the year is a mad rush to wrap things up before the holidays, and so it was for the FDA. Notable regulatory decisions include the first drug approval for a prevalent ...
Trump administration withdraws FDA plan to ban menthol cigarettes in U.S.
The Trump administrations removed FDA's plan to ban menthol cigarettes. The Biden administration did not finalize the rule ...
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FDA’s accelerated approval pathway has a few potholes
The Health and Human Services Office of Inspector General has found that, in a few cases, FDA officials veered from the accelerated approval pathway.
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FDA’s Catch-Up Plan on Cosmetics Faces Likely Regulatory Delays with Change in Administrations
The U.S. Food and Drug Administration (FDA) has been playing catch-up on three long-delayed proposed rules required under the Modernization ...
What Are the Side Effects of Red Dye No. 3? FDA Bans Food, Drink Dye
The FDA banned the use of Red Dye No. 3 based on a petition asking that the agency follow a specific guideline.
Red states can pick up the legal fight against mifepristone, judge rules
Missouri, Kansas and Idaho can press forward with their lawsuit to restrict access to the abortion drug mifepristone, a ...
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FDA Authorizes Zyn Nicotine Pouches
FDA officials said Thursday that Zyn contains ... pointing to videos of young people popping Zyn and other pouches that have racked up millions of views on social media platforms.