In 2002, the Food and Drug Administration rejected an antidepressant known as gepirone. In 2004, it gave the drug the thumbs-down again. Ditto in 2007. And yet, an FDA advisory committee will be ...

Credit: Getty Images. Exxua (previously named Travivo) is a novel oral serotonin 1A receptor agonist. The Food and Drug Administration (FDA) has accepted the resubmitted New Drug Application (NDA) for ...

EXXUA has demonstrated significant improvement in depression symptoms in clinical trials involving more than 5,000 patients and, notably, has no warnings or adverse events related to sexual ...

After multiple prior rejections, gepirone hydrochloride extended-release (ER; Exxua) gained FDA approval for the treatment of major depressive disorder (MDD) in adults, drugmaker Fabre-Kramer ...

Gepirone is a new chemical entity, and EXXUA is the first-in-class selective serotonin 5HT1a receptor agonist approved by the United States Food and Drug Administration ("FDA") for the treatment of ...

Surviving a long road, novel next-generation treatment offers hope for major depressive disorder. After being rejected five times by regulators over two decades, Exxua (gepirone extended-release), ...

SILVER SPRING, Md. -- An FDA advisory committee voted 9-4 against recommending approval for a not-so-new antidepressant, gepirone hydrochloride extended release (ER), that has already been denied ...

We have long known that so-called “antidepressants” are not highly effective because they fail so many of their licensing trials for the Food and Drug Administration. When a company develops a drug, ...

LONDON, Nov 3 (Reuters) - U.S. regulators have rejected GlaxoSmithKline Plc's experimental drug gepirone ER for adults with major depression. The U.S. Food and Drug Administration (FDA) issued a not ...

Aytu enters the over $22 billion United States prescription major depressive disorder ("MDD") market with the first-in-class oral selective serotonin 5HT1a receptor agonist for adults with MDD. EXXUA ...