US FDA, CDC investigating multi-state listeria outbreak
Listeria outbreak linked with supplemental shakes now stands at 12 deaths, FDA says
Listeria Outbreak From Frozen Shakes Kills 12, Sickens 38
A listeria outbreak tied to frozen shakes served in hospitals and long-term care facilities has sickened at least 38 people and killed 12, according to the U.S. Food and Drug Administration (FDA). The shakes,
FDA moves to rehire medical device staffers fired only days earlier
Barely a week after mass firings at the Food and Drug Administration, some probationary staffers received unexpected news over the weekend: The government wants them back. Beginning Friday night, FDA employees overseeing medical devices and other key areas received calls and emails notifying them that their recent terminations had been “rescinded effective immediately,
US FDA approves Medtronic's medical device for Parkinson's disease
Medtronic Parkinson's Disease Brain Stimulation System Gets FDA Approval
Medtronic said the Food and Drug Administration approved a brain stimulation system for people afflicted with Parkinson's disease. The medical technology company said the regulator approved BrainSense Adaptive deep brain stimulation and BrainSense Electrode Identifier.
 · 8hAxios Vitals on MSN
FDA OKs adaptive brain pacemaker for Parkinson's treatment

NY, Zyn and FDA

NY lawmaker introduces bill to ban Zyn, other flavored nicotine pouches after FDA's support of product
 · 1dPsychology Today
Zyn Nicotine Pouch Products Get FDA Approval for Adults
NY legislator proposes ban on flavored nicotine pouches including Zyn, despite FDA backing
Generic Wegovy, Ozempic compounds may become harder to get as FDA removes drug from shortage list
Ozempic and Wegovy are no longer in shortage, FDA says
Novo's Wegovy and Ozempic removed from US FDA shortage list, compounders on notice
The U.S. Food and Drug Administration said on Friday there was no longer a shortage of Novo Nordisk's popular weight-loss and diabetes drugs, Wegovy and Ozempic, a declaration that will curtail widespread sales of cheaper copies made by compounding pharmacies.

Nuts Recall Update

Nuts Recall Update as FDA Sets Risk Level
The FDA Set This Recalled Pancake And Waffle Mix To Its Highest Risk Level. Here's What To Know.
Nut recall set at highest FDA level
A batch of recalled Wegmans nuts has been issued a Class II risk classification by the U.S. Food and Drug Administration (FDA). Newsweek reports United Natural Trading Inc. has issued a voluntary recall for Wegmans organic dry roasted salted almonds in January because they were labeled incorrectly as cashews on the back.
Trump officials ask CDC, FDA to use gender notice on restored websites
The Trump administration had directed health agencies to place a notice condemning “gender ideology” on health webpages that had been earlier taken down.
FDA rehires staff to its medical devices division after mass layoffs
The Trump administration is reinstating some employees in the Food and Drug Administration's medical devices division after dozens were laid off as part of a government-wide cost-cutting initiative led by billionaire Elon Musk and his Department of Government Efficiency,
Yearslong shortage of popular weight-loss and diabetes drugs is resolved, FDA says
Shortages of Ozempic and Wegovy that have been in place for more than two years have been resolved, as supplies of the popular diabetes and obesity treatments continue to improve, federal regulators said Friday.
FDA To Review Teva and Alvotech Drug That Could Compete With Regeneron's Eylea
Key Takeaways Teva Pharmaceutical Industries and partner Alvotech said the Food and Drug Administration agreed to review their AVTO6 treatment for eye disorders. The treatment is a biosimilar that could compete with Regeneron Pharmaceuticals’ Eylea.
FDA delays when a final rule on what foods can be labeled as ‘healthy’ goes into effect
The US Food and Drug Administration’s new standards for foods before they can be labeled as “healthy” on their packaging will go into effect about two months later than planned, according to a government document scheduled to be published in the Federal Register on Tuesday.

Mirum, FDA and Pharmaceuticals

US FDA approves Mirum Pharma's genetic disorder drug
FDA Approves Mirum Pharmaceuticals Treatment for Lipid-Storage Disease
The Food and Drug Administration approved Mirum Pharmaceuticals' Ctexli to treat Cerebrotendinous Xanthoma, a very rare lipid-storage disease. The approval makes Ctexli, or chenopod, the first FDA-approved drug to treat CTX,
FDA approves Mirum treatment for cerebrotendinous xanthomatosis
The Food and Drug Administration approved Ctexli for the treatment of cerebrotendinous xanthomatosis in adults. “Ctexli is the first