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BioWorld - Sunday, May 3, 2026
Home » Topics » Regulatory

Regulatory
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U.S. flag on columned building
NIH

Stopgaps help some survive, but over time, NIH funding is unique

Aug. 25, 2025
By Anette Breindl
No Comments
On Thursday, the Supreme Court handed the Trump administration another significant victory in its attempts to defund NIH-sponsored research. In a 5-4 decision, the justices paused the June 16 order of U.S. District Judge William Young to restore funding for hundreds of canceled NIH research grants focusing on gender and diversity, equity and inclusion (DEI). The funding had first been cut through a series of executive orders shortly after President Donald Trump resumed power in January.
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Medtronic Hugo platform

Medtronic expects Hugo robotic system to drive growth

Aug. 22, 2025
By Shani Alexander
Medtronic plc expects its Hugo robotic-assisted surgery system to be a key growth driver, especially when it receives U.S. FDA approval. Already approved for use in Europe, Medtronic recently received CE mark for the Ligasure technology to be used with the Hugo RAS system, expanding its capabilities for gynecologic, general and urologic procedures, across the region.
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Artryas Salix

FDA clears Artrya’s Salix AI coronary plaque module

Aug. 22, 2025
By Tamra Sami
The U.S. FDA has cleared Artrya Ltd.’s 510(k) for its Salix coronary plaque (SCP) module that is a bolt-on module to the company’s Salix coronary anatomy platform.
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Device in heart

NICE tells docs to pay less for TAVR when possible

Aug. 22, 2025
By Mark McCarty
The U.K. National Institute for Health and Care Excellence has recommended that physicians in the U.K. use the least expensive, clinically appropriate TAVR device when possible, concluding a pricing review that commenced roughly a year ago.
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Biopharma regulatory actions and approvals July 2025

US FDA approves six NMEs in July; Kalvista, PTC, Regeneron rise

Aug. 22, 2025
By Amanda Lanier
No Comments
The U.S. FDA approved 17 drugs in July, down from 23 in June, bringing the year-to-date total to 125. Through July, 2025 remains the third-highest count in BioWorld’s records, trailing 135 approvals in 2024 and 126 in 2020.
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U.S. flag on columned building

Stopgaps help some survive, but over time, NIH funding is unique

Aug. 22, 2025
By Anette Breindl
No Comments
On Thursday, the Supreme Court handed the Trump administration another significant victory in its attempts to defund NIH-sponsored research. In a 5-4 decision, the justices paused the June 16 order of U.S. District Judge William Young to restore funding for hundreds of canceled NIH research grants focusing on gender and diversity, equity and inclusion (DEI). The funding had first been cut through a series of executive orders shortly after President Donald Trump resumed power in January.
Read More
Illustration for inflammatory bowel disease
Gastrointestinal

IND open for Shattuck’s SL-325 for inflammatory bowel disease

Aug. 22, 2025
No Comments
Shattuck Labs Inc. has reported that its IND from the U.S. FDA for SL-325 for the treatment of inflammatory bowel disease is now in effect. The company expects to commence a phase I trial in healthy volunteers in the third quarter of this year.
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Signots Stelo

Signos adds AI to CGM to drive weight loss

Aug. 21, 2025
By Annette Boyle
Signos Inc. landed U.S. FDA clearance for its over-the-counter glucose monitoring system, which combines Dexcom Inc.'s non-prescription Stelo continuous glucose monitor with an AI-powered platform focused on weight management and metabolism. The sensor transmits glucose readings to a smartphone app that interprets the data, provides guidance for healthy habits and educates the user.
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Novocure's Optune Lua

Novocure files PMA for use of Optune in pancreatic cancer treatment

Aug. 21, 2025
By Holland Johnson
Novocure GmbH said it submitted a premarket approval application to the U.S. FDA for its Optune Lua wearable device tumor treating fields therapy for the treatment of locally advanced pancreatic cancer.
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K-Organoid Consortium
Drug design, drug delivery & technologies

South Korea forms new organoid consortium for nonanimal testing

Aug. 21, 2025
By Marian (YoonJee) Chu
No Comments
South Korea’s Ministry of Food and Drug Safety (MFDS) launched a new industry-academia-research consortium to support the nation’s organoid industry, expected to grow in light of the U.S. FDA’s shift away from animal testing in the development of novel drugs.
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