GLP-1 INTELLIGENCE
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10 articles
FDA Launches the Rare Disease Framework Initiative to Develop a Holistic, Fit-For-Purpose Framework for Rare Disease Drug Development
The U.S. Food and Drug Administration, a division within the U.S. Department of Health and Human Services (HHS), today announced the Rare Disease Framework Initiative to reimagine the development of drugs and biologics for rare diseases.
FDA Approves First Treatment for Certain People With BCG-Unresponsive Bladder Cancer
FDA Approves First Treatment for Certain People With BCG-Unresponsive Bladder Cancer
Setmelanotide for the Treatment of Acquired Hypothalamic Obesity
New England Journal of Medicine, Volume 395, Issue 15, Page 1562-1564, October 15, 2026.
Roche Puts Up $100M to Pursue Promising But Competitive New Target in Obesity
Roche gains global rights to a Rona Therapeutics RNA interference drug designed to target ALK7, a genetically validated target for obesity and other metabolic indications. The growing field of companies pursuing ALK7 includes GSK and Arrowhead Pharmaceuticals. The post Roche Puts
FDA Seeks Public Input to Support Ibogaine Research
The U.S. Food and Drug Administration today announced a request for information (RFI) describing approaches the agency is considering for the design of early-phase clinical trials of ibogaine drug products and seeking public input on those approaches.
FDA Approves First Heart Valve Designed to Grow with Children
The U.S. Food and Drug Administration today approved the Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve for pediatric patients with congenital pulmonary valve disease.
Survodutide Once Weekly in Adults with Obesity and Type 2 Diabetes
New England Journal of Medicine, Ahead of Print.
FDA Launches Nationwide Effort to Expand Scientific Expertise and Consumer Voices to Advisory Committees
The U.S. Food and Drug Administration today announced a broad, nationwide recruitment effort to expand the range of qualified voices and perspectives on its advisory committees— the independent bodies that inform some of the most consequential decisions in American public health.
FDA Investigation Leads to Charges Against Two Indian Nationals Involved in Transnational Counterfeit Drug Distribution Scheme
The U.S. Attorney’s Office for the Middle District of Florida and the Criminal Division of the U.S. Department of Justice today announced federal charges against Swapnadip Roy, 33, and Vicky Ramancha, 37, both Indian nationals.
Retatrutide, a Triple Hormone Receptor Agonist, for Treatment of Obesity
New England Journal of Medicine, Ahead of Print.
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