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 ...
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The FDA Has Approved a New Copper IUD
For the first time in 40 years, the FDA has approved a new hormone-free IUD. Miudella, a low-dose copper insert, can prevent pregnancy for up to three years and will be available later this year, ...
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Drug compounders sue FDA over Novo Nordisk’s Ozempic, Wegovy (updated)
Drug compounders aren’t ready to give up their ability to produce off-brand versions of Novo Nordisk’s weight-loss drug ...
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FDA approves rapid initiation of Sublocade for opioid use disorder
The FDA has approved label changes for once-monthly Sublocade, helping to reduce possible barriers to treatment initiation ...
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FDA Delays Effective Date for Final Healthy Rule
On February 25, 2025, the U.S. Food and Drug Administration (FDA) delayed the effective date for its final “Healthy” rule from February 25, 2025 ...
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FDA approves first adaptive deep brain stimulation system for Parkinson’s disease
The FDA has approved BrainSense, an adaptive deep brain stimulation system that can adjust therapy for Parkinson’s disease in ...
New FDA-Approved Diabetes Drug Slashes Heart Attack and Stroke Risk
Sotagliflozin significantly reduces heart attacks and strokes in high-risk patients with diabetes and kidney disease, ...
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Compounders Sue FDA for Declaring Ozempic, Wegovy Shortage Over
The Outsourcing Facilities Association, a trade group representing compounders, filed a similar lawsuit in October last year ...