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BioWorld - Wednesday, July 1, 2026
Breaking News: Science fiction realized: BCI tech is hereBreaking News: Science fiction realized: BCI tech is here
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Regulatory actions for Nov. 21, 2025

Nov. 21, 2025
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Accord, Advanz, Alexion, Alvotech, Amgen, Astrazeneca, Bayer, Nuvalent, Regeneron.
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Other news to note for Nov. 21, 2025

Nov. 21, 2025
Biopharma happenings, including deals and partnerships, and other news in brief: Aperture, Applied, Celltrion, Microbiotix, Novartis, Persephone, Trioar.
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In the clinic for Nov. 21, 2025

Nov. 21, 2025
Clinical updates, including data readouts and publications: Innovent, Jyong, Orbus, Revalesio.
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Financings for Nov. 21, 2025

Nov. 21, 2025
Biopharmas raising money in public or private financings, including: Biovaxys, Cassidy, Moderna.
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Appointments and advancements for Nov. 21, 2025

Nov. 21, 2025
New hires and promotions in the biopharma industry, including: CASI, Thryv.
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FDA Approved seal
Biopharma regulatory actions and approvals October 2025

Jascayd for idiopathic pulmonary fibrosis among 20 October US nods

Nov. 21, 2025
By Amanda Lanier
No Comments
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.
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CDC logo on website

RFK skirts promise as CDC alters vaccine-autism webpage

Nov. 21, 2025
By Karen Carey
No Comments
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.
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Flag of Scotland against blue sky

Scotland sets out 10-year plan to double its life sciences sector

Nov. 21, 2025
By Nuala Moran
No Comments
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.
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Multiple sclerosis-damaged myelin

Contineum’s PIPE-307 misses in midstage MS study

Nov. 21, 2025
By Lee Landenberger
No Comments
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.
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Doctors examining lung scans

Taiho, Cullinan file rolling NDA on phase I/II zipalertinib data

Nov. 21, 2025
By Tamra Sami
No Comments
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.
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