Drugs

FDA OKs New Schizophrenia Drug

FDA has approved Bristol-Myers Squibb’s Cobenfy (xanomeline and trospium chloride) capsules for treating schizophrenia in adults. The approval marks a major shift in treating the condition as Cobenfy is the first drug to target cholinergic receptors, rather than dopamine receptors, which have long been the standard of care for these patients, an FDA release says.

Approval was based on data from two five-week clinical trials involving adults diagnosed with schizophrenia. The primary efficacy measure was a score change in the Positive and Negative Syndrome Scale (PANSS), which assesses schizophrenia symptoms,” FDA says. “In both studies, the participants who received Cobenfy experienced a meaningful reduction in symptoms from baseline to Week 5 as measured by the PANSS Total Score compared to the placebo group,” it says.

The agency warns that the drug can cause side effects such as urinary retention, increased heart rate, and decreased gastric movement. Additionally, there is a risk of liver damage, particularly in patients with impaired liver function, and it is not recommended for those with moderate or severe kidney impairment, it says.

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