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BioWorld - Thursday, July 2, 2026
Home » Topics » North America » U.S.

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Lab mouse
Drug design, drug delivery & technologies

FDA wants a shift away from animal testing

April 14, 2025
By Lee Landenberger
In a roadmap to change animal testing requirements for INDs, the U.S. FDA said its new approach will improve drug safety, hasten the evaluation process, and lower costs for companies and patients. It’s another step in a process of changing rules put in place decades ago.
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Dexcom G7 CGM

FDA clears Dexcom G7 15 Day

April 11, 2025
By Annette Boyle
The battle to claim the continuous glucose monitor with the longest wear time continues with Dexcom Inc.’s G7 15 Day continuous glucose monitor gaining U.S. FDA clearance on April 10 for adults with diabetes. The company said it now takes the lead with the 15-day duration, but Abbott Laboratories also offers 15 days of useful life for its Freestyle Libre 3 plus.
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David Luria Ziv Menshes

Cardiovia Viaone epicardial access system secures US FDA clearance

April 11, 2025
By Shani Alexander
Cardiovia Ltd.' Viaone epicardial access system received U.S. FDA clearance for treating cardiac arrhythmias. The device provides clinicians with a safe and minimally invasive technology to reach the heart’s outer surface, known as the pericardial space, without the need for a sharp needle, which can cause perforation.
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Novartis radioligand manufacturing

Novartis boosting US manufacturing with $23B investment

April 11, 2025
By Nuala Moran
Two days after pharma companies sounded an alarm that their investments were headed out of Europe, Novartis AG has announced plans to increase investment in the U.S. by $23 billion, bringing the total it invests over the next five years to nearly $50 billion.
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Bradley Burnam, CEO, Turn Therapeutics

Spevigo so-so, innovator takes another Turn at IL-36 in eczema

April 11, 2025
By Randy Osborne
With a promising IL-36 inhibitor for atopic dermatitis (AD, or eczema) at the phase II stage, Turn Therapeutics Inc. has gained $75 million in post-public commitments and meanwhile is pursuing a grassroots strategy to keep the coffers in balance.
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Lab mouse

FDA wants a shift away from animal testing

April 11, 2025
By Lee Landenberger
In a roadmap to change animal testing requirements for INDs, the U.S. FDA said its new approach will improve drug safety, hasten the evaluation process, and lower costs for companies and patients. It’s another step in a process of changing rules put in place decades ago.
Read More
US flag, stock market chart, White House

Dems petition White House to ensure drug supply chains stay intact

April 10, 2025
By Mark McCarty
The Trump administration applied a 90-day hold on nation-specific tariffs, but a group of 26 House Democrats urged the administration to think carefully before acting on a threat to impose tariffs on pharmaceuticals.
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Lunit Insight MMG

AI-enhanced mammogram readings are better, but ignored

April 10, 2025
By Marian (YoonJee) Chu
AI could significantly improve the value of patient recalls following mammography, but so far radiologists seem reluctant to rely on computer-aided readings. Radiologists tend to trust their own judgment – and that of their colleagues – in mammogram readings far more than AI-based diagnostics, even when the AI is much more accurate, a prospective trial analysis published in Radiology by Karolinska Institutet researchers found.
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CGM sensor
Patents

Patent filed for multiweek, multitarget CGM-like wearable sensor

April 10, 2025
By Simon Kerton
Researchers from the University of Cincinnati filed for protection of an electrochemical aptamer-based biosensor technology with improved sensitivity and longevity, which has the potential for monitoring several biomarkers over sustained periods.
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UK government invests £500M in health data research service

April 10, 2025
By Nuala Moran
The U.K. government is to invest £500 million (US$645 million) in a health data research service that will provide a single point of access to national-scale anonymized patient records, ending the need to navigate different systems or make multiple applications to use information.
Read More
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