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BioWorld - Wednesday, December 31, 2025
Home » Topics » North America » U.S.

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US flag and HHS logo

HHS to cut staffing levels by 20,000 under efficiency initiative

March 27, 2025
By Mark McCarty
The U.S. Department of Health and Human Services HHS reported a plan to reduce staffing by 10,000 in an immediate reduction, which when paired with retirement initiatives will drop staffing by as many as 20,000.
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Nanosonics Coris endoscope reprocessing platform

FDA clears Coris system for cleaning reprocessed endoscopes

March 27, 2025
By Tamra Sami
The U.S. FDA gave the green light to Nanosonics Ltd.’s Coris system via de novo clearance for reducing infection risk by delivering improved cleaning outcomes for flexible endoscopes, especially the complex channels of endoscopes that are prone to biofilm build up.
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Illustration of ovary, uterus and endometrial cancer.

Acrivon narrows focus for ACR-368 in endometrial cancer

March 27, 2025
By Jennifer Boggs
Acrivon Therapeutics Inc. provided updated phase II data for checkpoint kinase candidate ACR-368, highlighting promising response rates for biomarker-positive patients with endometrial cancer and raising the possibility of an accelerated pathway in the second-line setting.
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BIO survey points to ‘damaging impacts’ of Trump tariffs

March 27, 2025
By Nuala Moran
A survey of members of the Bioindustry Innovation Organization (BIO) has exposed what is at stake for the sector, on both sides of the Atlantic, if proposed tariffs are imposed on pharmaceutical imports to the U.S. "A staggering 94% of biotech firms anticipate surging manufacturing costs if tariffs are placed on imports from the EU,” according to BIO.
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Brain illustrated with pills
Neurology/psychiatric

Disease-modifying Alzheimer’s drugs are ‘drivers of change’

March 27, 2025
By Nuala Moran
The first disease modifying therapies for Alzheimer’s may have limited utility in some senses, but they will be a force for change, providing momentum and altering the way governments as payers, and health systems as carers, think about the disease.
Read More
Partial view of woman holding paper made intestines over stomach

Uresta raises $3M to stop urinary leaks

March 26, 2025
By Annette Boyle
Resilia Inc., dba Uresta, raised $3 million to launch its device to stop stress urinary incontinence in women. The flexible, insertable device braces the bladder and compresses the urethral passage to reduce or eliminate leakage during exercise, when coughing or laughing or when a woman just doesn’t want to worry about it. BDC Capital led the funding with a $1.5 million investment.
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Bhattacharya-Makary

Senate votes in Makary, Bhattacharya at FDA and NIH

March 26, 2025
By Mark McCarty
The U.S. Senate has approved the nominations of two key members of the Trump administration, Marty Makary as FDA commissioner and Jay Bhattacharya as NIH director. While these are two of the most critical appointments for the Trump administration, the Senate still has two other important appointments in queue, including the directors of the Centers for Medicare & Medicaid Services and the CDC.
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Dexcom G7 CGM

FDA says changes in Dexcom G6, G7 sensors constitute misbranding

March 26, 2025
By Mark McCarty
The U.S. FDA’s March 4, 2025, warning letter to Dexcom Inc. is a well-detailed but heavily redacted document explaining the agency’s misgivings about procedures such as monitoring of acetaminophen content in glucose test dishes.
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Brain illustrated with pills

Disease-modifying Alzheimer’s drugs are ‘drivers of change’

March 26, 2025
By Nuala Moran
The first disease modifying therapies for Alzheimer’s may have limited utility in some senses, but they will be a force for change, providing momentum and altering the way governments as payers, and health systems as carers, think about the disease.
Read More

Acrivon narrows focus for ACR-368 in endometrial cancer

March 26, 2025
By Jennifer Boggs
Acrivon Therapeutics Inc. provided updated phase II data for checkpoint kinase candidate ACR-368, highlighting promising response rates for biomarker-positive patients with endometrial cancer and raising the possibility of an accelerated pathway in the second-line setting.
Read More
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