With phase I/II data in hand, Taiho Pharmaceutical Co. Ltd. and Cullinan Therapeutics Inc. began filing a rolling NDA to the U.S. FDA for accelerated approval of zipalertinib to treat patients with locally advanced or metastatic non-small-cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations who previously received platinum-based chemotherapy. Read More
Contineum Therapeutics Inc.’s midstage study of its multiple sclerosis drug, PIPE-307, missed its primary and secondary endpoints, dropping the stock on Nov. 21. Top-line phase II results from the Vista study of the M1 receptor agonist PIPE-307 for treating relapsing-remitting multiple sclerosis saw no significant changes in binocular 2.5% low contrast letter acuity in the treatment arms, a key efficacy measure. Read More
The Scottish government has published a strategy setting out a roadmap to more than double the size of Scotland’s life sciences sector over the next 10 years. The most recent data show the sector currently contributes £10.5 billion (US$13.8 billion) in turnover to the economy, supporting 46,000 jobs. The aim of the strategy is to increase this to £25 billion by 2035. Read More
Changes to a U.S. CDC website regarding autism and vaccines has sparked a backlash from numerous scientific and other groups, placing HHS Secretary Robert F. Kennedy Jr. (RFK) in the spotlight once again for appearing to break promises made earlier this year to secure his nomination. Read More
A significant share of the risk and heritability of attention-deficit hyperactivity disorder (ADHD) is explained by rare genetic variants. A study led by scientists from Aarhus University in Denmark has uncovered their weight in this condition and identified three variants that will help to better understand their role, the risk of developing it, or its comorbidities, in contrast with the common and more frequent variants associated with ADHD. Read More
The U.S. FDA cleared 20 drugs in October 2025, up from 17 in September, 18 in August and 17 in July, bringing the year’s total to 181 approvals through the first 10 months. Two new molecular entities (NMEs) gained U.S. approval in October: Boehringer Ingelheim GmbH’s Jascayd and Bayer AG’s Lynkuet. Read More
Biopharma happenings, including deals and partnerships, and other news in brief: Aperture, Applied, Celltrion, Microbiotix, Novartis, Persephone, Trioar. Read More
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Accord, Advanz, Alexion, Alvotech, Amgen, Astrazeneca, Bayer, Nuvalent, Regeneron. Read More
