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Regulatory
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SonioAI

US FDA clears Sonio Suspect for fetal anomaly detection

Feb. 24, 2025
By Annette Boyle
The U.S. FDA hasn’t taken up criminal justice as a sideline, but it did just clear Sonio Suspect. Far from a social miscreant, Suspect improves detection of fetal anomalies by 22 points by automatically detecting multiple types of abnormal findings and allows for detection as early as 11 weeks of gestation.
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Oral medication

Mirum’s Ctexli wins FDA nod in cerebrotendinous xanthomatosis

Feb. 21, 2025
By Jennifer Boggs
Though it’s been used off-label for more than three decades to treat cerebrotendinous xanthomatosis, Mirum Pharmaceuticals Inc.’s chenodiol gained an official U.S. FDA nod Feb. 21 as the first drug approved specifically for treating the rare autosomal recessive lipid storage disease.
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FDA Approved stamp with pills, bottle, blister pack
Biopharma regulatory actions and approvals January 2025

Astrazeneca, Vertex, Axsome secure US FDA approvals in January

Feb. 21, 2025
By Amanda Lanier
The U.S. FDA approved 12 drugs in January, falling below the 2024 monthly average of 19. Only three new molecular entities received approval, trailing the yearly average of just over four per month.
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U.S. FDA headquarters

Raft of FDA job cuts may slow med-tech approvals

Feb. 21, 2025
By Holland Johnson
In response to the news of reported layoffs at the U.S. FDA over the weekend, Advanced Medical Association president and CEO Scott Whitaker said in press release that these “significant job cuts could have a very negative impact on patient care in this country.”
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Scissors cutting a row of black and red paper dolls

Still waiting for the dust to settle at US FDA, throughout HHS

Feb. 20, 2025
By Mari Serebrov
With massive terminations, data removals, holds on U.S. government funding, cancellation of various programs and meetings, the potential for 25% tariffs on medical products and a multitude of court challenges and appeals, the dust is flying thick at the FDA, NIH and throughout the Department of Health and Human Services (HHS).
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Boston Scientific Farawave Nav

Boston Sci obtains CE mark for Farapulse navigation mapping system

Feb. 20, 2025
By Shani Alexander
Boston Scientific Corp. recently received CE mark for its navigation-enabled Farawave Nav ablation catheter and Faraview mapping software to be used with its Farapulse pulsed field ablation (PFA) system. The technologies are expected to improve physicians’ understanding of patients’ atrial fibrillation to enable treatment using the Farapulse PFA system.
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Various pills laid across a target

Pharmaceuticals named as tariff target, starting at 25%

Feb. 19, 2025
The prospect of U.S. tariffs on pharmaceuticals became more than just speculation this week, with President Donald Trump saying those tariffs likely would begin at 25% and climb over the year. His comments came in response to a question at a Feb. 18 news conference that followed the signing of two unrelated executive orders. Asked about the planned rate for tariffs on semiconductors and pharmaceuticals, Trump responded that it would be 25% and higher and it would “go very substantially higher over [the] course of a year.”
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Infant exam

China prioritizes mental health, pediatric care in 2025

Feb. 19, 2025
By Marian (YoonJee) Chu
China’s National Health Commission is designating a three-year period from 2025 to 2027 as the “years of pediatric and mental health services,” in line with a new pledge to achieve eight initiatives in the health care sector aimed at servicing underserved populations.
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Monica Bertagnolli, former director, U.S. NIH
Policy

AAAS 2025: Former NIH head Bertagnolli sounds warning on funding cuts

Feb. 19, 2025
By Nuala Moran
The former head of the U.S. NIH has sounded a warning that the uncertainty caused by the Trump Administration’s funding cuts and layoffs is blocking “critical work” and “paralyzing” biomedical research. “Every time we launch a new program, every time we continue to commit resources to ongoing work, those are important decisions that we make every single day, and in times like this, that decision-making is paralyzed,” said Monica Bertagnolli, who stood down as director of the NIH on Jan. 17.
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Monica Bertagnolli, former director, U.S. NIH

AAAS 2025: Former NIH head Bertagnolli sounds warning on funding cuts

Feb. 18, 2025
By Nuala Moran
The former head of the U.S. NIH has sounded a warning that the uncertainty caused by the Trump Administration’s funding cuts and layoffs is blocking “critical work” and “paralyzing” biomedical research. “Every time we launch a new program, every time we continue to commit resources to ongoing work, those are important decisions that we make every single day, and in times like this, that decision-making is paralyzed,” said Monica Bertagnolli, who stood down as director of the NIH on Jan. 17.
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