Drugs

FDA Accepts Amylyx’ Alzheimer Drug NDA

FDA has accepted an Amylyx Pharmaceuticals NDA for its AMX0035, an experimental therapy to address pathways leading to neuronal cell death in Alzheimer’s patients. The agency set a 6/26 PDUFA target date to act on the NDA, reports MedCity News.

The agency granted the NDA priority review and plans to schedule an advisory committee meeting to discuss its safety and efficacy, the report says.

The submission is based on results from a Phase 2 trial that met its main endpoint of slowing disease progression. While FDA initially said Amylyx needed to conduct a Phase 3 trial before seeking regulatory approval, company discussions with the agency led to filing the NDA based on the Phase 2 study results, MedCity News says. A Phase 3 trial is now underway and expects to enroll 600 patients.

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