Steve Duffy

Digital Content Editor

Most Recent Articles by Steve Duffy

FDA to Review Eylea for the Treatment of Non-Proliferative Diabetic Retinopathy

FDA to Review Eylea for the Treatment of Non-Proliferative Diabetic Retinopathy

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The sBLA includes results from the Phase 3 PANORAMA trial, which enrolled 402 patients with NPDR.

Akcea and Ionis Receive Complete Response Letter for WAYLIVRA from FDA

Akcea and Ionis Receive Complete Response Letter for WAYLIVRA from FDA

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"We are extremely disappointed with the FDA's decision. We continue to feel strongly that Waylivra demonstrates a favorable benefit/risk profile in people with FCS," said Akcea CEO, Paula Soteropoulos.

FDA Approves First Mobile App for Use in Preventing Pregnancy

FDA Approves First Mobile App for Use in Preventing Pregnancy

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The algorithm was designed to account for sperm survival, variation in cycle length, ovulation day, temperature fluctuations and the length of the follicular and luteal phases of the menstrual cycle.

Canagliflozin Trial for T2D With CKD Stopped Early Due to Positive Results

Canagliflozin Trial for T2D With CKD Stopped Early Due to Positive Results

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A clinical trial assessing canagliflozin (Invokana; Janssen) as an addition to standard-of-care in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) has been stopped early after meeting its pre-specified efficacy criteria.

New Romosozumab BLA Includes Data from Additional Osteoporosis Trials

New Romosozumab BLA Includes Data from Additional Osteoporosis Trials

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Evenity is a bone-forming monoclonal antibody designed to inhibit the activity of sclerostin, which allows the drug to rapidly increase bone formation and reduce bone resorption simultaneously.

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