Drugs

Priority Review for Axsome AXS-05 Depression Drug

FDA has accepted for filing and granted priority review to Axsome Therapeutics’ NDA for its AXS-05 (dextromethorphan bupropion) for treating major depressive disorder (MDD). The company says AXS-05 is a novel, oral, investigative NMDA receptor antagonist with multimodal activity. FDA has set 8/22 as the PDUFA action date for its review.

The agency previously granted AXS-05 breakthrough therapy designation 3/2019 for treating MDD. It also granted a breakthrough therapy designation 6/2020 for treating Alzheimer’s disease.

The company says the NDA is supported by results from two trials in patients with a confirmed diagnosis of moderate to severe MDD that demonstrated statistically significant improvements in depressive symptoms with AXS-05 compared to placebo or active controls.

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