Biologics

Vanda Antibody BLA for Pustular Psoriasis

Vanda Pharmaceuticals has filed a BLA for imsidolimab and its use in treating generalized pustular psoriasis, a rare and potentially fatal inflammatory skin disease with no broadly effective long-term therapies. The disorder is driven in many cases by mutations in the IL36RN gene that disrupt the body’s natural inflammation regulation, causing sudden flares of widespread pustules, redness, fever and systemic illness that can require hospitalization. The company has requested priority review, which, if granted, would provide a review decision in mid-2026.

The submission for the investigational IL-36 receptor–blocking monoclonal antibody is based on data from two global Phase 3 trials, GEMINI-1 and GEMINI-2. In GEMINI-1, a 45-patient randomized study, a single intravenous infusion of imsidolimab led to rapid clinical improvement, according to the company. At four weeks, 53% of patients receiving imsidolimab achieved clear or almost clear skin, compared with 13% of patients on placebo.

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