The US FDA has rejected Denali's drug for the rare disease Hunter syndrome, namely tividenofusp alfa, with the original decision deadline pushed back after the delivery of additional pharmacological data without requiring new data on efficacy or safety.[1] The FDA has issued a warning to compounding pharmacy Hims & Hers for mass selling unapproved GLP-1 drug compounds as alternatives to approved weight loss and diabetes drugs.[2] The agency plans to use all enforcement tools, including seizures and injunctions, against companies promoting these products as generic or clinically proven.[2] A bipartisan group of US lawmakers backed legislation to advance antibiotics and other pharmaceutical innovations.[original content] In January 2026, the FDA approved Sentynl Therapeutics' Zycubo as the first treatment for pediatric patients with Menkes disease, a rare neurodegenerative disease caused by a genetic disorder of copper absorption.[3] Other FDA decisions are expected in neurology, such as on tolebrutinib for non-relapsing secondary progressive sclerosis, due in the first half of 2026.[1] The FDA also issued a request for information on gluten labeling in foods to improve ingredient information and prevent cross-contact.[3]