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The FDA has issued a new final guidance intended to facilitate the development and assessment of regenerative medicine therapy (RMT) products CBER regulates through identifying and recognizing voluntary consensus standards (VCS). Read More
A study published in JAMA showed that glucagon-like peptide 1 (GLP-1) agonists medications used for weight loss — Ozempic and Wegovy (both semaglutide) and Mounjaro (liraglutide) — come with increased risks of gastrointestinal adverse events such as pancreatitis, bowel obstruction, and gastroparesis, the slowing or stopping of the movement of food from the stomach to the small intestine. Read More
Britain and the EU have mended their two-year post-Brexit science funding standoff, as the island nation rejoins Horizon, the EU’s largest source for research collaboration and funding. Read More
FDA’s expedited regulatory programs cut up to two years off both clinical development and approval times for more than half of the drugs approved from 2015-2022, according to a new study. Read More
The FDA’s draft guidance on psychedelic drug trials excludes many nurses from serving as lead and assistant monitors, according to sponsors, nurses and nonprofits amongst the more than 160 comments the agency received. Read More
This month, FDAnews tackles studies for two promising obesity drugs, a first-of-its-kind pneumococcal vaccine for adults and a partial clinical hold for a blood cancer drug. Read More
Ten years and $2.5 billion — that’s what it takes, on average, to bring a new drug to market in the United States. Artificial intelligence (AI) promises to supercharge this process, drastically reducing the time and costs of bringing life-saving therapies to market. Read More
More than 60 percent of the drugs approved last year won their FDA nod on the basis of a single clinical trial that was conducted by the drug sponsor, a new analysis has determined. Read More
Vistagen’s fasedienol (PH94B) nasal spray for social anxiety disorder (SAD) showed a statistically significant reduction in anxiety measures during a public speaking challenge, using a measure of subjective units of stress score. Read More