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PharmaDeviceNews
Representative image: A retina specialist prepares an office-based ocular injection, reflecting Everads Therapy’s push to advance suprachoroidal drug delivery for diabetic macular edema and other retinal diseases.
Medical Devices & Diagnostics

Can Everads Injector change how ophthalmology drugs reach the back of the eye?

Retina drugs are improving, but delivery remains the bottleneck. Everads Therapy is testing whether suprachoroidal access can change that.

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Representative image: A bioprosthetic aortic valve in a surgical setting highlights the growing focus on long-term heart valve durability as Edwards Lifesciences’ 10-year RESILIA tissue data sharpen the debate over lifetime valve planning in aortic stenosis care.
Medical Devices & Diagnostics

Edwards Lifesciences’ RESILIA data may shift the valve debate, but not without caveats

Valve durability is becoming a lifetime-care question. Edwards Lifesciences’ 10-year RESILIA data raise the stakes for heart teams.

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Representative image: Arrowhead Pharmaceuticals’ REDEMPLO approval in Australia highlights the growing role of RNAi therapies in treating familial chylomicronemia syndrome and severe triglyceride disorders.
Pharma & Biotech

Arrowhead just unlocked Australia for REDEMPLO, but the bigger RNAi test starts now

Arrowhead has regulatory momentum in rare lipid disease. The harder test is turning REDEMPLO approval into durable global uptake.

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Representative image: AstraZeneca’s TRUQAP prostate cancer push highlights the growing role of targeted therapy and PTEN testing in metastatic hormone-sensitive prostate cancer treatment.
Pharma & Biotech

Why AstraZeneca’s TRUQAP ODAC vote could reshape PTEN-deficient prostate cancer treatment

TRUQAP has ODAC support, but toxicity and survival maturity still matter. AstraZeneca’s prostate cancer expansion now faces FDA’s final test.

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Representative image: Corcept Therapeutics’ dazucorilant survival signal in amyotrophic lateral sclerosis highlights how ALS clinical trials are shifting attention from short-term functional scores to longer-term survival outcomes.
Pharma & Biotech

A failed ALS trial still showed a stunning survival signal. Can Corcept turn it into Phase 3 proof?

A failed ALS endpoint meets a striking survival signal. Corcept now faces the harder test: proving dazucorilant in Phase 3.

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Representative image: A child undergoing an eye examination in a modern ophthalmology clinic, reflecting Sydnexis’ Phase 3 SYD-101 data focus on low-dose atropine treatment for fast-progressing pediatric myopia.
Pharma & Biotech

Can Sydnexis’ SYD-101 data sharpen the case for low-dose atropine in fast-progressing pediatric myopia?

Pediatric myopia is rising fast, but U.S. drug options remain thin. Sydnexis’ SYD-101 data may sharpen the regulatory race.

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Representative image: A hematology clinician reviews treatment data in a clinical lab setting as Incyte’s FDA approval of once-daily Jakafi XR highlights the next phase of ruxolitinib therapy for myelofibrosis, polycythemia vera and graft-versus-host disease.
Pharma & Biotech

Can Jakafi XR defend Incyte’s ruxolitinib franchise as dosing convenience becomes strategic?

Jakafi is mature, but dosing still matters. Incyte’s Jakafi XR approval could extend ruxolitinib’s strategic life in hematology.

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Representative image: A clinician uses a portable ultrasound and elastography system for non-invasive liver and spleen assessment, highlighting how E-Scopics’ FDA-cleared Hepatoscope enhancements could support point-of-care liver disease diagnostics and cirrhosis complication monitoring.
Medical Devices & Diagnostics

Why E-Scopics’ new Hepatoscope clearance could reshape point-of-care liver diagnostics

Liver diagnostics need speed and scale. E-Scopics’ Hepatoscope clearance tests whether bedside elastography can move deeper into routine care.

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Representative image of breast cancer genomic testing and pathology analysis, highlighting how Agendia’s MammaPrint and BluePrint data could support more biology-led treatment decisions in early-stage Basal-Type breast cancer.
Medical Devices & Diagnostics

How Agendia’s breast cancer assays are testing the limits of race-based clinical assumptions

Race matters in care access, but tumor biology may drive response. Agendia’s FLEX data sharpen the breast cancer equity debate.

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Representative image of an advanced endoscopic ultrasound-guided gastrointestinal drainage procedure, reflecting TaeWoong Medical USA’s FDA-cleared SPAXUS stent and the growing role of minimally invasive therapeutic EUS in pancreatic pseudocyst, walled-off necrosis, and high-risk gallbladder drainage care.
Medical Devices & Diagnostics

Why TaeWoong Medical USA’s SPAXUS clearance could sharpen the race in therapeutic EUS

Therapeutic EUS is getting more competitive. TaeWoong Medical USA’s SPAXUS clearance now faces the harder test: real-world adoption.

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