Drugs

Bristol Myers sNDA for Camzyos

FDA has accepted for a review a Bristol Myers Squibb supplemental NDA for Camzyos (mavacamten) for an expanded indication to reduce the need for septal reduction therapy (SRT). The therapy is currently approved for treating adults with symptomatic New York Heart Association Class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms. The company says that currently it is recommended that many patients with severe symptomatic obstructive hypertrophic cardiomyopathy undergo SRT, which often requires either an open-heart surgical procedure or septal ablation procedure. The agency has set a 6/16 user fee review action target date.

The submission was based on data from the Phase 3 VALOR-HCM study, a randomized, double-blind, placebo-controlled study that evaluated CAMZYOS in patients with symptomatic, obstructive HCM, according to the company. It says it met its primary and all secondary endpoints with a “high degree of statistical significance” and no new safety signals observed.

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