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BioWorld - Thursday, April 9, 2026
Home » Topics » Regulatory » NIH

NIH
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NIH launches new center to replace animal testing with organoids

Sep. 25, 2025
By Karen Carey
No Comments
About five months after the U.S. FDA disclosed its roadmap to move away from animal testing in favor of new approaches for biopharma drug development, the U.S. National Institutes of Health (NIH) said it is awarding $87 million in contracts over three years to launch the Standardized Organoid Modeling Center.
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Hand holding a pink slip or termination notice against a blurred office background

More US federal layoffs, future of SBIR on the table

Sep. 25, 2025
By Mari Serebrov
No Comments
The struggle to avoid a partial U.S. government shutdown at midnight Sept. 30 is getting a lot of attention, as the stakes increase every day of the political standoff. Meanwhile, Sept. 30 also could be the end of the 43-year-old Small Business Innovation Research (SBIR) program, which has been a funding boon for biotech and med-tech startups, if Congress can’t come together on a reauthorization bill.
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FDA icons and doctor

New FDA fast track for repurposed drugs?

Sep. 23, 2025
By Mari Serebrov
One Comment
Breaking with its long-held, oft-recited mantra that observational studies are great for generating hypotheses but not as evidence for approval, the U.S. FDA is initiating the approval of leucovorin calcium tablets for patients with cerebral folate deficiency, a neurological condition that affects folate transfer into the brain.
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Vaccine vial and syringe

Kennedy: All US vaccines to be reviewed

Sep. 10, 2025
By Mari Serebrov
No Comments
Speaking at a Sept. 9 media briefing on the newly released Make America Healthy Again Strategy, U.S. Health and Human Services Secretary Robert Kennedy confirmed what could be the worst fears of many vaccine experts.
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Vaccine vial and syringe

Kennedy: All US vaccines to be reviewed

Sep. 9, 2025
By Mari Serebrov
No Comments
Speaking at a Sept. 9 media briefing on the newly released Make America Healthy Again Strategy, U.S. Health and Human Services Secretary Robert Kennedy confirmed what could be the worst fears of many vaccine experts.
Read More
Illustration of immunoglobulin A with secretory IgA
Gastrointestinal

NIH support for Lactiga’s sIgA antibody for IBD

Sep. 5, 2025
No Comments
Lactiga US Inc. has received an award from the NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to advance the development of its secretory IgA (sIgA) antibody for inflammatory bowel disease (IBD).
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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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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
Dollar sign in light bulb on yellow background
Immune

NIH grant supports evaluation of Trethera’s TRE-515 for lupus

Aug. 20, 2025
No Comments
Trethera Corp. has been awarded a $3 million Small Business Innovation Research (SBIR) grant from the National Institute of Health (NIH) to support evaluation of Trethera’s lead candidate, TRE-515, for the treatment of systemic lupus erythematosus (lupus).
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Lawsuit provides excuse to revive vaccine safety task force

Aug. 15, 2025
By Mari Serebrov
No Comments
In the wake of a lawsuit from the anti-vaccine nonprofit group U.S. Health and Human Services (HHS) Secretary Robert Kennedy founded, HHS is reviving a vaccine safety task force that’s been lifeless for nearly three decades.
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