Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Abbvie, Amneal, Crinetics, Eli Lilly, Regeneron, Sanofi.
Biopharma happenings, including deals and partnerships, and other news in brief: Fractyl Health, Harrow, Melt, N4, Ocuvex, Onconetix, OSE, Sanofi, SRI, Theratechnologies.
In August 2025, BioWorld logged 95 clinical trial updates across phases I to III, compared to 140 tracked in July and 254 in June. Among them, 15 phase III studies delivered positive results, while one trial each reported a failure and mixed outcome.
Anaphylaxis rates caused Larimar Therapeutics Inc.’s stock (NASDAQ:LRMR) to take a hit on the latest data from an open-label study with nomlabofusp in the neuromuscular disease Friedreich’s ataxia (FA), but the company is targeting a BLA submission to seek accelerated approval in the second quarter of next year.
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