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FDA Drug Approval Decisions Expected in March 2025
The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for ...
FDA approves opioid-free pain medication with 'no sign of addiction'
A new opioid-free pain medication was approved by the FDA on Thursday, marking a non-addictive alternative for patients.
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FDA approves 'ketamine' nasal spray for depression — here's everything you need to know
A nasal spray that contains esketamine — a potent derivative of ketamine — can now be taken on its own to treat adults with ...
FDA approves Symbravo for acute treatment of migraine in adults
The U.S. Food and Drug Administration has approved Axsome Therapeutics' Symbravo (meloxicam and rizatriptan) for the acute ...
Vertex Pharmaceuticals' non-opioid pain medication gets FDA approval
A non-opioid pain medication made by Vertex Pharmaceuticals has received approval for adults from the Food and Drug ...
The FDA pulls key DEI initiative for cancer studies from its website
A Food and Drug Administration project to promote diversity in clinical studies of cancer treatments was removed from the ...
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FDA webpages on clinical trial diversity removed after Trump orders
The website changes raise concerns about “the interference of politics with the study and the practice” of science and ...
Ozempic Approved By FDA For Kidney Disease—In Ultra-Popular Drug’s Latest Approval
Regulators have approved the drug as a treatment for weight loss, Type 2 diabetes and lowering the risk of heart attacks and ...
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Trump Administration’s DEI Executive Order and the Impact on FDA’s DAP Draft Guidance: Top Points
For more than a decade, the Food and Drug Administration (FDA) has made diversity in clinical trials a focus, including by issuing guidance, ...