Hundreds of industry leaders have signed a letter to FDA Director Marty Makary, M.D., about the importance of having a predictable Regulatory Agency (United States Food and Drug Administration – FDA), citing a survey in which 82% of biopharma respondents said they were concerned about the FDA’s ability to function.
Macrophage-toxic bacteria from patients with ulcerative colitis worsen gut inflammation in mice
Researchers take a step toward limb regeneration: In a significant step toward full-limb regeneration, researchers at Texas A&M University have identified a fibroblast growth factor as a key protein that can regenerate an entire finger joint, including soft tissue. “Our expectation is that if we can figure out all the factors that regenerate a finger, then we could apply those factors anywhere on the rest of the arm, or even a leg, and regrow a limb,” said Assistant Professor Lindsay Dawson.
During the second meeting of the US Food and Drug Administration’s (FDA) Digital Health Advisory Committee (DHAC), members of the panel seemed shocked and, at times, lost for words when grappling with the Agency’s discussion questions surrounding the potential regulation of generative Artificial intelligence (AI)-enabled digital mental health medical.
Costa Rica has asked the United States to avoid medical device tariffs as the country becomes a manufacturing hotspot for major companies.
Mud-dwelling cable bacteria construct metal organic frameworks to grow
Autoimmune diseases are numerous, affect mostly women: There are more than 100 autoimmune diseases that collectively affect tens of millions of people, predominantly women, and diagnosing autoimmune diseases can be challenging due to vague and overlapping symptoms that mimic other illnesses. Multiple tests, including blood tests for specific antibodies, are often required. New research is focusing on reprogramming the immune system to cure autoimmune diseases.
Llamas, alpacas source of broad-spectrum snake antivenom: Scientists working with llamas and alpacas have created a new antivenom that neutralizes venom from 17 species of deadly African snakes by combining eight (8) nanobodies derived from the animals’ immune responses. When tested with mice, the cocktail protected against multiple venoms and reduced tissue damage, suggesting a new path toward safer and broader antivenom treatments for humans.
Trial of transplanted pig kidneys begins: The first clinical trial of pig kidney transplants is underway, with United Therapeutics announcing a successful initial procedure at NYU Langone Health. The trial, which may expand to 50 participants, will follow recipients of gene-edited pig kidneys. Genes that may trigger rejection are knocked out, and some human genes that promote compatibility are added.
The Senate has rejected bipartisan ACA subsidy bills as millions face doubled premiums when financial assistance expires at the end of 2025.