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BioWorld - Wednesday, March 25, 2026
Home » Topics » Regulatory

Regulatory
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Environmental Protection Agency - US EPA

EPA to reconsider air standards for ethylene oxide

March 28, 2025
By Mark McCarty
In a move that undoubtedly has the unspoken support of the medical device industry, the U.S. Environmental Protection Agency (EPA) reported it will revisit several rules governing emissions that affect a broad swath of industries.
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Australia flag with microscope, test tubes

Australia looks to Asia as Trump administration threatens funding

March 28, 2025
By Tamra Sami
Australia’s top universities are looking more to Asia for research collaborations following threats from the Trump administration to stop funding research at institutions that don’t comply with U.S. narratives.
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Illustration of hole in vessel wall with repair process in progress

Sanofi adds to hemophilia arsenal with FDA nod for Qfitlia

March 28, 2025
By Jennifer Boggs
Sanofi SA gained U.S. FDA approval for fitusiran as a first-in-class siRNA therapy for hemophilia. Branded Qfitlia, the antithrombin-lowering therapy is indicated for use as a prophylactic treatment to prevent or reduce bleeding episodes in people with hemophilia A or B, with or without inhibitors, and joins the small but growing group of non-factor therapy options, with the advantage of a broad label and a convenient dosing regimen.
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Myst it again: Milestone gets a CRL for its heart spray

March 28, 2025
By Lee Landenberger
Milestone Pharmaceuticals Inc.’s heart rhythm-restoring calcium channel blocker for paroxysmal supraventricular tachycardia (PSVT) has yet another obstacle in its way. 
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Alzheimer’s drug Kisunla rejected by European regulators

March 28, 2025
By Nuala Moran
The EMA has rejected the Alzheimer’s disease therapy Kisunla (donanemab) from Eli Lilly and Co., saying the benefits of the anti-amyloid antibody do not outweigh the risks of edema and hemorrhage in the brain, known as amyloid-related imaging abnormalities (ARIA).
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Vykat XR

First Prader-Willi treatment Vykat XR FDA-approved: Soleno soars

March 27, 2025
By Karen Carey
Becoming the first treatment for rare genetic disorder Prader-Willi syndrome, breakthrough therapy drug DCCR (diazoxide choline) gained U.S. FDA approval as Vykat XR the evening before its March 27 PDUFA date, sending shares of developer Soleno Therapeutics Inc. up 38%.
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Abbott Labs Volt

Abbott’s Volt enters the PFA fray with CE mark

March 27, 2025
By Annette Boyle
Abbott Laboratories snagged a CE mark for its Volt pulsed field ablation catheter for atrial fibrillation several months earlier than the mid-year approval expected. The Abbott Park, Ill.-based company has begun Volt’s commercial launch with the physicians who participated in its European clinical trials and plans to expand to other users on the continent in the second half of 2025.
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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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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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