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The regulator granted the application priority review for this indication, assigning a Prescription Drug User Fee Act (PDUFA) date of 30 September 2026. Camzyos is currently approved for

The agreement covers Hanmi’s candidate that uses its LAPSCOVERY long-acting platform technology. Sonefpeglutide combines Hanmi’s proprietary technology and has previously achieved approval from the US Food and Drug

The agreement covers antibody-drug conjugates with new payloads and multi-specific antibodies featuring distinct immune-engaging mechanisms. The portfolio consists of eight drug candidates originating from Innovent Biologics and four

Elunetirom is an oral, once daily, brain-penetrant CNS thyroid hormone receptor (CNS-TR) agonist in development for bipolar depression and major depressive disorder (MDD). The therapy is intended as

The therapy uses patients’ immune cells, developed into mature macrophages, which are then re-infused to break down scar tissue and promote the growth of healthy liver cells. In

The approval allows Datroway to be used as a first-line treatment for adults with unresectable or metastatic TNBC who cannot receive programmed cell death protein 1 (PD-1) or

The site is anticipated to expand the company’s production capacity for iPSC-based research products and services to four times its previous levels. Fujifilm Cellular Dynamics plans to use

The designation follows two randomised, controlled Phase III trials that showed significant pain reduction, good tolerability, and no evidence of dependence. A Phase III comparator study found VER-01

Jascayd is said to be the first phosphodiesterase 4B (PDE4B) inhibitor with antifibrotic and immunomodulatory effects to be approved for these uses. Japan is the fourth country to