Drugs

NDA for PTSD Therapy Resubmitted

Resilient Pharmaceuticals reportedly has resubmitted an NDA for its midomafetamine (MDMA) capsules for a proposed indication of treating post-traumatic stress disorder (PTSD). Resilient (formerly the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS) and Lykos Therapeutics) resubmitted the application following a 2024 Complete Response Letter (see story), which recommended additional research related to durability of response, safety characterization, and steps to minimize potential for bias.

Reacting to news about the resubmission, MAPS noted that the refiling was made without a new Phase 3 study. “We knew the FDA wasn’t saying no, just not yet,” the group said. “We believed the data were valid and that adverse events and clinical outcomes were reported accurately, though positive adverse events had not been gathered at that time. Despite partial functional unblinding, the therapists provided high-quality care in treating the placebo subjects as well as the subjects who received MDMA.”

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