Patients with chronic spontaneous urticaria 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), a Bruton’s tyrosine kinase inhibitor administered by pill twice daily. Read More
A U.S. FDA complete response letter (CRL) citing manufacturing concerns has stepped into the way of a rare genetic disorder treatment. Fortress Biotech Inc. and its subsidiary, Cyprium Therapeutics Inc., said the letter in response to the NDA for CUTX-101, an injectable formulation of copper histidinate, noted cGMP deficiencies at the facility where the Menkes disease treatment is manufactured. Read More
Pharma 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. Read More
Kyorin Pharmaceutical Co. Ltd. is licensing Hinge Bio Inc.’s multispecific antibody-based therapy HB-2198 in Japan for multiple autoimmune indications, starting with systemic lupus erythematosus. Read More
Full-Life Technologies Ltd. announced Sept. 29 the completion of a $77 million financing, comprising $50 million in series C equity and $27 million in debt financing, which will be used to advance a portfolio of radiopharmaceuticals and radionuclide-drug conjugates worldwide. Read More
Caught between the start of fiscal 2026 and a congressional funding standoff that shut down much of the U.S. federal government Oct. 1, the FDA will not be able to collect 2026 user fees until Congress agrees on a continuing resolution or a 2026 appropriations bill. Read More
Mari Serebrov, BioWorld’s regulatory editor, shares how the publication’s 35-year commitment to fact-based, expert-driven journalism helps readers navigate complexity and make informed decisions. Read More
New hires and promotions in the biopharma industry, including: Arecor, Aurion, Dispatch, Engene, Medera, Nanocell, Ntx, Septerna, Tentarix, Tonix. Read More
Clinical updates, including data readouts and publications: Anavex, Atyr, Cellectar, Endeavor, Eupraxia, Kardigan, Merck, Metsera, Nanobiotix, Opus Genetics, Orion, Scynexis, Upstream. Read More
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Abbvie, Acurx, Clear Scientific, Disc Medicine, FOXG1 Research Foundation, JCR, Kexing, Medipal, Umoja, Vicore. Read More
