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U.S. Food and Drug Administration

Pharma & Biotech

How Lux Infusion plans to improve Qfitlia access and treatment coordination

Lux Infusion adds Sanofi's Qfitlia to its hemophilia services, combining specialty pharmacy access with insurance and clinical support.

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Medical Devices & Diagnostics

Can SurGenTec’s Vantage system reduce surgical instrumentation and sterilisation requirements?

SurGenTec licenses FDA-cleared Vantage from Allevion Medical, expanding disposable spinal decompression options. Examine its clinical and commercial potential.

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Pharma & Biotech

Celltrion presents LIBERTY-CD and LIBERTY-UC post hoc findings at ACG 2026

Celltrion's Zymfentra shows 71.4% Crohn's remission in a matched analysis, with new findings on treatment interruption and antibodies.

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Pharma & Biotech

Skyrizi reaches 73.1% remission in a Crohn’s subgroup. Can AbbVie secure a new FDA dosing option?

AbbVie reports new Skyrizi and Rinvoq Crohn's disease data, including Phase III remission results and long-term findings. Examine the evidence.

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Pharma & Biotech

Can Spruce Biosciences prove its Sanfilippo treatment slows brain decline? New data could strengthen its FDA case

Spruce Biosciences prepares MPS IIIB disease progression data as TA-ERT approaches its FDA filing and confirmatory trial milestones.

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Medical Devices & Diagnostics

Bayer’s experimental PET scan detected 94% of cardiac amyloidosis cases. Can it identify the disease earlier?

Bayer's amyloidosis PET tracer showed 94% sensitivity in Phase III. New HFSA analyses examine earlier diagnosis and finerenone treatment gaps.

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Medical Devices & Diagnostics

A sutureless heart valve showed 99.7% freedom from deterioration. What do Corcym’s seven-year data really establish?

Corcym's Perceval Plus reports 99.7% freedom from valve deterioration in extended follow-up. Examine the MANTRA data and durability questions.

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Medical Devices & Diagnostics

Can Stuart Therapeutics’ ST-100 heal damaged corneas? A new FDA filing opens a critical test

Stuart Therapeutics files an FDA amendment for ST-100 corneal wound trials, with collagen repair evidence and 2027 milestones in focus.

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Pharma & Biotech

GlyphAgo boosted drug bioavailability 6.8-fold. Can Seaport solve agomelatine’s liver safety challenge?

Seaport's GlyphAgo improved agomelatine exposure in Phase 1. New Phase 2 trials will test efficacy, liver safety and anxiety outcomes.

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Medical Devices & Diagnostics

Genentech’s vamikibart sustains vision gains at 52 weeks, but mixed Phase III results complicate FDA review

Genentech's vamikibart sustained vision gains at 52 weeks, but mixed Phase III results leave questions ahead of a July 2027 FDA decision.

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