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BioWorld - Wednesday, February 11, 2026
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Regulatory actions for April 2, 2025

April 2, 2025
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bright Uro.
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Pills, bottle atop $100 bill

US to impose ‘kind reciprocal’ tariffs on country-by-country basis

April 2, 2025
By Mari Serebrov
After several on-again, off-again tariff threats, U.S. President Donald Trump made it official April 2: Beginning immediately, the U.S. will levy “kind reciprocal” tariffs on countries across the world. Focusing on the numbers, Trump didn’t mention whether any goods would be exempt from the new tariffs, and the executive order he signed at the Rose Garden ceremony wasn’t available as of press time. However, in concluding his remarks, Trump said the pharmaceutical industry would “come roaring back” in the U.S., because if biopharma companies don’t, they will be facing big taxes.
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US flag and HHS logo

Kennedy called to Senate HELP hearing on HHS reorg

April 2, 2025
By Mari Serebrov
U.S. Sens. Bill Cassidy, R-La., and Bernie Sanders, I-Vt., invited Robert Kennedy to testify April 10 before the Senate Health, Education, Labor and Pensions (HELP) Committee for the first time in his capacity as Health and Human Services (HHS) secretary. The HELP invitation went out April 1 amid an outcry as thousands of employees across HHS agencies were being notified of their immediate termination and many lawmakers demanded answers about the mass layoffs.
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4-9-Abbott-Triclip.png
AAC25

Hospitalizations decline shows clearer benefit in Triclip study

April 1, 2025
By Annette Boyle
The two-year results of TRILUMINATE trial showed the first objective benefit to use of Abbott Laboratories’ Triclip transcatheter tricuspid edge-to-edge repair device in a presentation at ACC.25, the American College of Cardiology’s annual scientific session held March 29-31 in Chicago and simultaneously published in Circulation.
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Edwards-SAPIEN3-12-6.png

Edwards’ Early TAVR refutes surveillance recs for aortic stenosis

April 1, 2025
By Annette Boyle
Don’t wait. Edwards Lifesciences Corp.’s additional insights from the Early TAVR trial showed a clear benefit for transcatheter aortic valve replacement (TAVR) in patients with asymptomatic aortic stenosis.
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Illustration of lung cancer, DNA double helix

FDA clears Gleamer, Azmed AI-powered tools for chest X-rays

April 1, 2025
By Shani Alexander
Two French startups, Gleamer SAS and Azmed SAS, received clearance from the U.S. FDA for their AI-powered tools for chest X-rays. They join an increasing number of companies developing software tools to help clinicians detect a range of abnormalities on images, enhancing diagnostic accuracy, reducing delays and improving patient outcomes.
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AI-generated illustration of DNA double helix

FTC eyeing 23andme’s disposition of genomic data

April 1, 2025
By Mark McCarty
The financial collapse of direct-to-consumer genetic testing pioneer 23andme Holding Co. is already one of the more notable developments of 2025, but the company’s customers have less to worry about with regard to their data.
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U.S. flag on columned building

FDA’s loss in lawsuit opens door to LDT promotion

April 1, 2025
By Mark McCarty
The U.S. FDA famously lost a lawsuit over its final rule for regulation of lab-developed tests (LDTs), but Jeff Shapiro of King & Spalding told BioWorld that the implications of this decision go beyond FDA regulation of clinical lab operations.
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Appointments and advancements for April 1, 2025

April 1, 2025
New hires and promotions in the med-tech industry, including: Adagio Medical, Cano Health, Neogenomics, Shimadzu Medical Systems.
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In the clinic for April 1, 2025

April 1, 2025
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Advanced Medical Balloons, Cleerly, Medican Technologies, Neo Medical .
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