Biologics

Susvimo OK’d for Diabetic Macular Edema

FDA has approved a Genentech supplemental BLA for Susvimo (ranibizumab injection) 100 mg/mL for treating diabetic macular edema (DME), a leading cause of vision loss in adults with diabetes. Susvimo is the first FDA-approved treatment shown to maintain vision in people with DME with fewer treatments than standard-of-care eye injections, the company says.

Approval was based on data from the Phase 3 Pagoda study, demonstrating that Susvimo sustained vision improvements in people with DME, with safety consistent with the known safety profile for Susvimo, according to the company. “In Pagoda, people with DME who received Susvimo refilled every six months achieved non-inferior improvements in vision compared with those receiving monthly 0.5 mg ranibizumab intravitreal injections (9.6 eye chart letters, similar to gaining two more lines on an eye chart, compared to 9.4 letters, respectively),” it says.

Susvimo was first approved in 2021 for treating wet or neovascular age-related macular degeneration.

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