Patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment now have a new oral treatment option, with the U.S. FDA’s approval of Novartis AG’s Rhapsido (remibrutinib). CRL blocks Menkes disease treatment CUTX-101A U.S. FDA complete response letter (CRL) citing manufacturing concerns has stepped into the way of a rare genetic disorder treatment. Pharma pools structural data to boost power of AI in drug discoveryPharma companies are collaborating to boost the power of artificial intelligence (AI) in drug discovery by allowing access to proprietary structural data to train a large language model. Burlingame, Calif.-based Hinge Bio will lead global development activities, and Kyorin will fund development, regulatory, marketing and commercialization activities in Japan and contribute a portion of investment to global development. Those carryover fees will allow the agency to continue reviewing drug and device applications submitted prior to the new fiscal year.