Drugs

Alnylam Pharma Amyloidosis Therapy Approved

FDA has approved an Alnylam Pharmaceuticals NDA for Amvuttra (vutrisiran), an RNAi therapeutic administered by subcutaneous injection once every three months for treating polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. Approval was based on nine-month data from the HELIOS-A Phase 3 study that showed the therapy significantly improved the signs and symptoms of polyneuropathy, with more than 50% of patients experiencing a halting or reversal of their disease manifestations, according to the company.

Regarding safety, the company says Amvuttra showed an “encouraging” safety and tolerability profile for nine months of dosing, and there were no drug-related discontinuations or deaths. The most common adverse events included arthralgia (11%), dyspnea (7%) and decreased vitamin A (7%).

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