Drugs

Vanda Files NDA for Antipsychotic Drug

Vanda Pharmaceuticals has filed an NDA for Bysanti (milsaperidone) for treating acute Bipolar I disorder and schizophrenia. The new chemical entity is believed to work by interacting with a host of neurotransmitter receptors in the brain, including the alpha-adrenergic receptor, serotonin receptors and dopamine receptors, according to the company.

The submission is based on data from several clinical studies assessing the efficacy and safety of Bysanti, including a bioequivalence study of the company’s Fanapt (iloperidone) and milsaperidone, which is the active metabolite of iloperidone, Vanda says. “We believe that milsaperidone represents a potential improvement over the clinical profile of Fanapt and has the potential to create sustained, long-term value in the treatment of psychiatric disorders, including Bipolar I disorder and schizophrenia, the indications already approved for Fanapt, as well as new indications such as MDD [major depressive disorder],” it says. “We initiated a Phase III clinical study for milsaperidone for MDD in the fourth quarter of 2024.”

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