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Representative image: A surgical team prepares a preserved donor heart in a high-tech transplant setting, reflecting the clinical and regulatory stakes behind United Therapeutics Corporation’s FDA-cleared UHeart xenotransplantation trial for end-stage heart failure.

Pharma & Biotech

Can United Therapeutics turn pig-heart xenotransplantation into a regulated clinical pathway?

by Pallavi Madhiraju
May 16, 2026
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A pig-heart trial is no longer just a scientific leap. United Therapeutics now faces the harder test of safety, scale, and regulation.

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POPULAR NEWS

Niagen Bioscience’s NB4168 has secured U.S. FDA Rare Pediatric Disease and European orphan designations as the company advances the experimental ataxia telangiectasia therapy toward human trials. Representative image.

Pharma & Biotech

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Representative image of a clinician reviewing skeletal imaging, illustrating Mirum Pharmaceuticals and Incyte’s zilurgisertib Phase 2 progress in fibrodysplasia ossificans progressiva and the rare disease treatment questions facing regulators.

Pharma & Biotech

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Representative image of biopharma laboratory research. Gilead Sciences and Merck’s latest Phase 3 updates highlight the promise of once-weekly HIV treatment with islatravir and lenacapavir, while raising fresh questions over Trodelvy’s lung cancer expansion strategy.

Pharma & Biotech

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TAGS

clinical trials Eli Lilly and Company European Medicines Agency FDA FDA approval immuno-oncology immunotherapy Inc. Johnson & Johnson medical devices oncology precision oncology rare disease U.S. Food and Drug Administration United States Food and Drug Administration

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