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United States Food and Drug Administration

Medical Devices & Diagnostics

Johnson & Johnson has a new dual-energy ablation platform, but will hospitals adopt it?

Find out how Johnson & Johnson’s dual-energy ablation system could reshape cardiac arrhythmia procedures.

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Medical Devices & Diagnostics

QT Imaging passed its first FDA inspection cleanly, but can adoption follow?

Find out how QT Imaging’s clean FDA inspection could support Breast Acoustic CT scale-up and breast imaging adoption.

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Pharma & Biotech

Pharvaris has an FDA review date for deucrictibant, but can it stand out?

Find out how Pharvaris’ deucrictibant could reshape oral treatment options for hereditary angioedema attacks.

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Medical Devices & Diagnostics

Presage Technologies SmartSpectra cleared for contactless vital signs monitoring

Find out how Presage Technologies’ SmartSpectra software uses phone cameras to measure pulse and breathing rate without sensors.

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Pharma & Biotech

Can CoRegen’s CRG-150 turn regulatory T cells into a solid tumour weapon?

Find out how CoRegen is advancing CRG-150 into human trials for metastatic breast cancer, prostate cancer and solid tumours.

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Medical Devices & Diagnostics

Can Movmedix turn LARS ACJ clearance into meaningful United States adoption?

Find out how Movmedix plans to launch its FDA-cleared LARS ACJ synthetic ligament system for severe shoulder joint injuries.

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Pharma & Biotech

LTZ Therapeutics secures FDA clearance for LTZ-232 Phase 1 cancer trial

Find out how LTZ Therapeutics is advancing LTZ-232 into a Phase 1 trial targeting macrophages in metastatic colorectal cancer.

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Pharma & Biotech

Alterity gains a streamlined FDA pathway as ATH434 faces its decisive clinical test

Alterity Therapeutics has secured an FDA-aligned Phase 3 pathway for ATH434 in multiple system atrophy, with one pivotal study potentially supporting an approval application.

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Pharma & Biotech

Galderma’s relabotulinumtoxinA FDA setback shifts attention to manufacturing readiness

Discover why FDA manufacturing concerns have delayed Galderma’s relabotulinumtoxinA approval and what the company must resolve next.

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Pharma & Biotech

FDA expands Skyrizi to children as AbbVie introduces weight-based 55 mg dose

AbbVie has secured a broad pediatric label for Skyrizi, adding both plaque psoriasis and active psoriatic arthritis alongside a new dose for children weighing less than 40 kg. The approval could strengthen treatment choice, although the evidence supporting the two indications is not equally direct.

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