FDA, weight loss drugs
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FDA conducts largest-ever baby formula safety test
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April 30 (Reuters) - The U.S. Food and Drug Administration on Thursday proposed excluding active ingredients for Novo Nordisk and Eli Lilly's weight-loss drugs on the list of drugs outsourcing facilities can use for compounding.
Katherine Szarama, who joined the FDA last year to serve as Vinay Prasad’s deputy, will now fill his shoes at CBER.
The surge in GLP-1 compounding began a few years ago when high demand triggered widespread shortages. Shortages of tirzepatide (resolved in December 2024) and semaglutide (resolved in February 2025) have since ended, though liraglutide remains on the shortage list with limited availability.
By Kamal Choudhury and Mariam Sunny April 30 (Reuters) - The U.S. Food and Drug Administration has approved Axsome Therapeutics' drug to treat agitation in patients with Alzheimer's disease, the company said on Thursday,
Known as transcranial direct-current stimulation, or tDCS, the technology is designed for at-home use, potentially offering a more accessible alternative to traditional therapies, according to The New York Times.
The Food and Drug Administration (FDA) is set to pilot test real-time clinical trials in the hopes of expediting results and feedback, federal health officials announced on Tuesday. At least two clinical trials by pharmaceutical companies AstraZeneca and Amgen will test the new system to alert FDA officials to study results in real time.
AUVELITY is a first-in-class treatment, which targets the NMDA and sigma-1 receptors, approved for agitation associated with dementia due to