Drugs

Susvimo Approved for Diabetic Retinopathy

FDA has approved Roche’s Susvimo (ranibizumab injection) 100 mg/mL for treating diabetic retinopathy (DR), a potentially blinding condition that affects almost 10 million people in the U.S. “It is the first and only FDA-approved continuous delivery treatment shown to maintain vision in people with DR with just one refill every nine months,” the company says. Susvimo is described as a refillable eye implant surgically inserted into the eye during an outpatient procedure that continuously delivers a customized formulation of ranibizumab over time.

Approval was based on positive one-year results from the Phase 3 Pavilion study. In the study, those treated with Susvimo refilled every nine months saw a “reduction in the severity of eye damage caused by diabetes, compared with those under monthly clinical observation who were treated with anti-VEGF injections as needed based on disease progression,” the company says. “Additionally, none of the participants receiving Susvimo required supplemental treatment at one year. Safety was consistent with the known safety profile for Susvimo.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome