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BioWorld - Sunday, January 18, 2026
Breaking News: BioWorld 2025 Year in ReviewBreaking News: BioWorld MedTech 2025 Year in ReviewBreaking News: Trump administration impacts continue to roil the life sciences sector
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Regulatory actions for April 28, 2025

April 28, 2025
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Clarius Mobile Health, Medtronic.
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US flag, stock market chart, White House

100 days of uncertainty

April 28, 2025
The first 100 days of the Trump administration have been nothing short of chaotic, both in the U.S. and throughout the world. Shining a light through the uncertainty, BioWorld continues to cover the administration’s latest policy decisions and actions affecting the life sciences sector, as well as their impacts across the globe. It’s all right here at Trump administration impacts.
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Med-tech gainers and losers for April 21-25, 2025

April 28, 2025
The top 10 med-tech stock gainers and losers for the week.
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Conceptual image for brain cancer treatment

FDA issues CRL for Telix's glioma imaging agent, wants more data

April 28, 2025
By Tamra Sami
The U.S. FDA issued a complete response letter (CRL) to Telix Pharmaceuticals Ltd. for its NDA for glioma imaging agent, TLX-101-CDx (floretyrosine F18 or 18F-FET, Pixclara), citing the need for additional confirmatory clinical evidence.
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Financial charts, test tubes, capsules, syringe

Med tech majors unfazed by tariffs

April 25, 2025
By Annette Boyle
First quarter earnings reports from Edwards Lifesciences Corp., Intuitive Surgical Inc. and Boston Scientific Corp. support trends seen earlier: Larger med-tech companies expect substantial tariff hits, but also have confidence that they can absorb the impact with fairly minor adjustments.
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Photomicrograph of liver biopsy in a patient with cirrhosis, showing bridging septal fibrosis and regenerative nodules.

Mursla Evoliver biopsy blood test granted breakthrough designation

April 25, 2025
By Shani Alexander
The U.S. FDA granted breakthrough device designation to Mursla Bio Ltd.'s Evoliver. The biopsy blood test uses extracellular vesicles to survey hepatocellular carcinoma in high-risk cirrhotic patients.
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Financings for April 25, 2025

April 25, 2025
Med-tech firms raising money in public or private financings, including: Cipher Surgical, Overture Life Secures.
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US flag, gavel, book

DOJ rolls out task force for review of burdensome regulation

April 25, 2025
By Mark McCarty
The U.S. Department of Justice recently announced the formation of a task force that will advocate the roll-back of regulations that affect a wide swath of sectors of the American economy. Health care is one of the areas of interest for the task force, which will examine state as well as federal regulations.
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In the clinic for April 25, 2025

April 25, 2025
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Cordis.
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Other news to note for April 25, 2025

April 25, 2025
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Corwave, Dragonfly Endoscopy, MedCAD, Medtronic, Sharps Technology, Sonomotion.
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