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BioWorld - Friday, April 10, 2026
Home » Topics » Regulatory » Legislation

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Lock on digital globe illustration

US Biosecure Act a vote away from law

Dec. 16, 2025
By Mari Serebrov
No Comments
“If at first you don’t succeed, try, try again” seems to be the motto of U.S. lawmakers – at least when it comes to the bipartisan Biosecure Act. After missing a ride last year in the must-pass annual defense spending bill, a version of the bill that seeks to protect the genetic data of Americans while securing U.S. pharmaceutical supply chains made it into the 2026 National Defense Authorization Act, which is now just a Senate vote away from becoming law.
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Lock on digital globe illustration

US Biosecure Act a vote away from law

Dec. 15, 2025
By Mari Serebrov
No Comments
“If at first you don’t succeed, try, try again” seems to be the motto of U.S. lawmakers – at least when it comes to the bipartisan Biosecure Act. After missing a ride last year in the must-pass annual defense spending bill, a version of the bill that seeks to protect the genetic data of Americans while securing U.S. pharmaceutical supply chains made it into the 2026 National Defense Authorization Act, which is now just a Senate vote away from becoming law.
Read More

US pediatric voucher making moves in Congress

Dec. 2, 2025
By Mari Serebrov
No Comments
The next stop on the comeback tour for the U.S. FDA’s Rare Pediatric Disease Priority Review Voucher program is the Senate, after the House unanimously passed the Mikaela Naylon Give Kids a Chance Act, H.R. 1262, Dec. 1.
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Emulate Chip R1 Brain

US, European biotechs lead budding organ-on-a-chip market

Nov. 20, 2025
By Marian (YoonJee) Chu
U.S. and European organ-on-a-chip specialty biotechnology companies are driving development of organ-on-a-chip technologies, fueled by the U.S. FDA’s decision to phase out animal testing for investigational new drugs.
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Emulate Chip R1 Brain

US, European biotechs lead budding organ-on-a-chip market

Nov. 19, 2025
By Marian (YoonJee) Chu
U.S. and European organ-on-a-chip specialty biotechnology companies are driving development of organ-on-a-chip technologies, fueled by the U.S. FDA’s decision to phase out animal testing for investigational new drugs.
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Amended stopgap spending bill includes full 2026 funding for FDA

Nov. 12, 2025
By Mari Serebrov
No Comments
The U.S. House is expected to vote late Nov. 12 on an amended continuing resolution (CR) to end the historic 43-day partial government shutdown. Already passed by the Senate, the CR would fully reopen the government and fund it through Jan. 30. President Donald Trump has said he will sign the CR, which ensures federal employees furloughed during the shutdown will receive back pay and will not be terminated.
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Digital globe illustrating pharma trade, tariffs

Rx tariff a stick and a carrot for US price, onshoring deals

Oct. 13, 2025
By Mari Serebrov
No Comments
Although U.S. President Donald Trump’s Oct. 1 start date for a hefty biopharma sector tariff has come and gone, the threat remains, serving as both a stick and a carrot to get drug companies to come to the table with their best deals.
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Patent law book and gavel

US Congress seeks to undo IP damage wrought by Supreme Court

Oct. 9, 2025
By Mari Serebrov
No Comments
A yearslong bipartisan effort to end the patent-eligibility chaos the U.S. Supreme Court created more than a decade ago could finally come to fruition with the current Congress.
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Laptop displaying FDA logo

New FDA submissions stalled during US government funding lapse

Oct. 1, 2025
By Mari Serebrov
No Comments
Caught between the start of fiscal 2026 and a congressional funding standoff that shut down much of the U.S. federal government Oct. 1, the FDA will not be able to collect 2026 user fees until Congress agrees on a continuing resolution or a 2026 appropriations bill.
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US Capitol at night

HHS rolls the numbers as shutdown looms for US government

Sep. 30, 2025
By Mari Serebrov
No Comments
Despite down-to-the-wire negotiations, the odds are that parts of the U.S. government will shut down at midnight Sept. 30, as Senate Democrats refused to support a seven-week, clean continuing resolution already passed by the House to keep the government funded while Congress hammers out fiscal 2026 spending bills.
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