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BioWorld - Thursday, April 2, 2026
Home » Topics » Regulatory » NIH

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Hand holding money plant

Wait almost over, as SBIR nears reauthorization

March 24, 2026
By Mari Serebrov
No Comments
A five-year reauthorization of the U.S. Small Business Innovation Research (SBIR) and Small Business Technology Transfer programs is just the president’s signature, or a few days, away.
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NIH Director Jay Bhattacharya

US lawmakers to Bhattacharya: Explain your answers

March 20, 2026
By Mari Serebrov
No Comments
NIH Director Jay Bhattacharya is being fact-checked on his off-the cuff responses at a Senate Health, Education, Labor and Pensions Committee hearing in February. The fact-checkers are nine Democratic lawmakers from Massachusetts, only one of whom (Sen. Ed Markey) is on the committee and attended the hearing. In fact, seven of those signing the March 17 letter that questioned Bhattacharya’s veracity aren’t senators. They serve in the House.
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Lab mouse and test tubes
Drug design, drug delivery & technologies

FDA, NIH mark milestones toward reducing animal testing

March 20, 2026
By Mari Serebrov
No Comments
In what the U.S. FDA has dubbed a milestone move toward fewer animal studies in drug development, the agency published a draft guidance to help sponsors validate new approach methodologies that can bring safe, effective drugs to market sooner based on human-centric data rather than starting off with nonclinical animal pharmacology and toxicology data.
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Lab mouse and test tubes

FDA, NIH mark milestones toward reducing animal testing

March 19, 2026
By Mari Serebrov
No Comments
In what the U.S. FDA has dubbed a milestone move toward fewer animal studies in drug development, the agency published a draft guidance to help sponsors validate new approach methodologies that can bring safe, effective drugs to market sooner based on human-centric data rather than starting off with nonclinical animal pharmacology and toxicology data.
Read More
Prescription drug bottles and pills

US GAO: March-ins not much of a solution for Rx prices

Feb. 19, 2026
By Mari Serebrov
No Comments
Driven by prescription drug prices and oft-repeated claims that nearly every drug developed in the U.S. owes its origins to taxpayer-funded research, watchdog groups and some lawmakers have led demands over the years for price to be considered a “reasonableness” factor in determining whether the government can march in on patents under the Bayh-Dole Act.
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NIH’s Bhattacharya to do double duty

Feb. 18, 2026
No Comments
U.S. NIH Director Jay Bhattacharya will be a lot busier in the days and weeks ahead. As if helming the NIH isn’t enough, Bhattacharya has been tapped to also serve as acting director of the CDC, an administration official confirmed to BioWorld.
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All of Us hits goal of representing all of US

Feb. 13, 2026
By Mari Serebrov
No Comments
More than a decade after it was first proposed, the U.S. Precision Medicine Initiative that grew into the NIH’s All of Us dataset has reached its target of collecting genetic and health-related data from 1 million Americans representative of the diversity across the country.
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NIH ends Xarelto arm of stroke trial due to safety, futility

Feb. 11, 2026
No Comments
Citing an increase in safety events and evidence of futility, the U.S. NIH stopped an investigational low-dose rivaroxaban arm of its Comparison of Anticoagulation and Antiplatelet Therapies for Intracranial Vascular Atherostenosis (CAPTIVA) trial.
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NIH Biomedical Research Center

Unburdening the past, HELPing NIH advance the future

Feb. 5, 2026
By Mari Serebrov
No Comments
In keeping with the congressional practice of passing major NIH reform legislation every 10 years, the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee took the first step in looking at what can be for the NIH while unburdening it from what has been over the past few years.
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U.S. Capitol building

Fiscal 2026 HHS spending bill in jeopardy?

Jan. 26, 2026
By Mari Serebrov
No Comments
After the U.S. House passed a package of spending bills Jan. 22 to fund several agencies and departments, including Health and Human Services, through fiscal 2026, the Senate was expected to quickly follow suit to ensure that no part of the federal government would shut down when the current continuing resolution expires Jan. 30. That was before a confrontation with Immigration and Customs Enforcement in Minnesota turned deadly over the weekend.
Read More
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