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United States Food and Drug Administration

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FDA Premarket Approval gives Implantica a US commercialization pathway for RefluxStop, a gastroesophageal reflux disease implant backed by long-term clinical evidence and designed to avoid encircling the esophagus. Representative image.
Pharma & Biotech

Sebela Pharmaceuticals reports positive ACG 2026 data for tegoprazan in reflux disease

Sebela's tegoprazan improves heartburn and regurgitation in Phase 3 NERD data. Examine efficacy, FDA review and competition.

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Editorial infographic highlighting Mirum Pharmaceuticals’ LIVMARLI (maralixibat) Phase 3 EXPAND trial, featuring liver illustrations, clinical research graphics and an October 12 results announcement, with emphasis on evaluating itching relief in additional rare liver diseases.
Pharma & Biotech

Mirum’s EXPAND study tests maralixibat for treatment-resistant cholestatic pruritus

Mirum will reveal LIVMARLI EXPAND Phase 3 results on October 12, testing whether maralixibat can treat itching in additional rare liver diseases.

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Editorial infographic highlighting LEO Pharma’s 21 dermatology research posters covering Anzupgo, Spevigo and Adbry, featuring skin tissue illustrations, clinical research imagery and key highlights on adolescent FDA review, clinical evidence and commercial growth prospects.
Pharma & Biotech

Why LEO Pharma is investing in real-world evidence for difficult dermatological diseases

LEO Pharma presents 21 dermatology posters covering Anzupgo, Spevigo and Adbry. Examine adolescent FDA review, clinical data and growth prospects.

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Editorial infographic highlighting Guardant360 CDx’s European CE marking for ETCAMAH patient selection, featuring a blood sample tube, ESR1 mutation test results, breast cancer imagery and a European map illustrating the role of liquid biopsy in advanced breast cancer treatment.
Medical Devices & Diagnostics

How Guardant360 CDx detects ESR1 mutations before breast cancer progresses on imaging

Guardant360 CDx gains European CE marking for ETCAMAH patient selection. See how ESR1 blood testing changes advanced breast cancer treatment.

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Editorial infographic illustrating ALYFTREK’s reported pancreatic function gains in young children with cystic fibrosis, featuring a medical body diagram highlighting the pancreas, clinical charts and pediatric treatment imagery, with emphasis on potential implications for future care.
Pharma & Biotech

Vertex ALYFTREK data show pancreatic function recovery in young children with cystic fibrosis

Vertex reports pancreatic function gains with ALYFTREK in young children with cystic fibrosis. See what the results mean for future treatment.

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Editorial infographic illustrating Affinia Therapeutics’ AFTX-201 BAG3 heart gene therapy programme, featuring an anatomical heart, DNA strands and clinical research imagery, with highlights on the 22-patient trial, promising animal results and unproven human safety and efficacy.
Pharma & Biotech

Affinia presents AFTX-201 preclinical data and UPBEAT trial design at HFSA 2026

Affinia advances AFTX-201 into a 22-patient BAG3 heart gene therapy trial after promising animal results. Human safety and efficacy remain unproven.

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Editorial infographic highlighting Medincell’s second FDA-approved drug, Weltruza, featuring an injectable medicine, FDA approval symbol, U.S. launch map and graphics illustrating clinical evidence, royalty potential and commercial outlook.
Pharma & Biotech

Can Weltruza become Medincell’s next growth driver after Uzedy commercial success?

Medincell gains a second FDA-approved drug as Teva prepares Weltruza's U.S. launch. See the clinical evidence, royalties and commercial outlook.

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Editorial infographic showing Urolution Medical’s OpenFlo catheter with medical tubing and sterile equipment, highlighting FDA clearance for 30-day drainage, upcoming clinical studies and manufacturing considerations.
Medical Devices & Diagnostics

FDA clears Urolution’s redesigned urinary catheter, but can OpenFlo improve patient outcomes?

Urolution Medical's OpenFlo catheter gains FDA clearance for 30-day drainage. Clinical studies and manufacturing will determine its next steps.

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Representative image of an intraocular lens procedure, illustrating how Alcon’s Clareon TruPlus launch could intensify competition in enhanced monofocal cataract lenses at ASCRS 2026.
Medical Devices & Diagnostics

Glaukos iDose TR cuts eye pressure beyond cataract surgery alone, but will the advantage last?

Glaukos iDose TR shows an additional 3.6 mmHg pressure reduction with cataract surgery. Examine the Phase 4 data and adoption implications.

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Pharma & Biotech

Can Merck’s remigromig compete with anti-VEGF treatments after BRUNELLO results?

Merck's remigromig met BRUNELLO's vision endpoint, but higher retinal complication rates complicate its potential in diabetic macular edema.

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