Drugs

FDA Accepts EMD Serono NDA for Tumor Drug

FDA has accepted for review an EMD Serono NDA for pimicotinib, a potential first-in-class systemic treatment for tenosynovial giant cell tumor (TGCT). The submission is based on data from the global Phase 3 MANEUVER study, which showed statistically significant tumor responses and sustained improvements in patient-reported outcomes, including pain, stiffness, range of motion and physical function, according to the company. The

In the placebo-controlled portion of MANEUVER, once-daily treatment met its primary endpoint by significantly improving objective response rate at 25 weeks, as assessed by a blinded independent review committee using RECIST criteria, the company says. Secondary endpoints tied to mobility, stiffness and pain also showed clinically meaningful improvements.

TGCT is described as a rare, locally aggressive tumor that develops in or around joints and can lead to progressive swelling, reduced mobility and irreversible joint damage if untreated or recurrent. While surgery remains the standard of care, many patients experience recurrence or face substantial functional impairment, creating demand for effective systemic therapies.

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