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Stem cell therapy enables paralyzed man to stand again: In a small clinical trial involving people with paralysis, one (1) person was able to stand on his own after receiving injections of neural stem cells derived from induced pluripotent stem cells, demonstrating the potential of reprogrammed cells in facilitating nerve regeneration. Another participant regained some movement; however, two (2) others showed no significant improvement.

As the compliance date for FDA’s new phased-in regulatory approach to laboratory-developed testing oversight nears, advocacy groups are attempting to see hew governmental standards set.

Panel: New body needed to guide US biomedical research: A panel convened by the National Academy of Medicine (NAM) recommends creating a new advisory body to guide United States biomedical research policy, aiming to better coordinate public and private funding to address health challenges like obesity and health inequities. The report highlights the need for a national strategic vision and improved funding collaboration across sectors, without necessarily increasing the NIH budget. It also emphasizes the importance of convergence science and diversifying the research workforce.

Next-generation obesity drugs are on the horizon: The success of semaglutide and tirzepatide have fueled the development of over 100 anti-obesity drug candidates, with an anticipated market value exceeding $100 billion by 2030. These emerging drugs, including bimagrumab to prevent muscle loss and retatrutide targeting multiple hormone receptors for enhanced weight loss, aim to improve efficacy and tolerability and address current treatment limitations.

The US Food and Drug Administration (FDA) announced plans to implement AI tools throughout the Agency to assist in conducting scientific reviews following the successful completion of a pilot program that incorporated generative AI into reviews.

The United States Food and Drug Administration (FDA) announced it will expand its effort to conduct unannounced inspections of foreign manufacturing facilities that produce medical products and foods.

Study with monkeys uncovers why people choke under pressure: A recent study with monkeys explores the phenomenon of “choking” under pressure, finding that heightened anxiety can interfere with brain function. The findings suggest that recreating “optimal” neural signatures could help humans enhance performance in high-pressure situations.

Researchers engineer toxic male mosquitoes: Researchers have developed a method to control mosquito populations by genetically engineering male mosquitoes to produce venom proteins from spiders and sea anemones, which are injected into females during mating to reduce their lifespan. The “toxic male technique” could quickly suppress outbreaks of diseases such as dengue fever and Zika without extensive insecticide use, according to a study in Nature Communications.

FDA urged to collaborate with EMA (European Medicines Agency) to accelerate rare disease drug approvals: A report by the National Academies of Sciences, Engineering and Medicine recommends that the FDA enhance transparency and collaborate with the European Medicines Agency to systematically review past rare disease drug applications and regulatory decision-making to expedite approvals. The report advises the EMA and FDA to create a continuously updated public database for these results, and also recommends Congress remove the Pediatric Research Equity Act orphan exemption.

CBD products truly are everywhere these days. From gummies to topical creams and now tampons, it seems there is no limit to where this trendy compound might appear. However, a recent FDA Warning Letter to Anne’s Daye (dba Tampon Innovations) serves as a blunt reminder to medical device manufacturers: you cannot just lace your products with CBD and expect FDA to be mellow about it. CBD products truly are everywhere these days.