Drugs

FDA Delays Clinical Hold Review on Neurizon ALS Drug

FDA has extended until 10/3 its review of a clinical hold response from Neurizon Therapeutics’ NUZ-001, its lead experimental treatment for amyotrophic lateral sclerosis (ALS). The agency’s standard review period for such responses is 30 days, but Neurizon said the delay stems from FDA-wide staffing cuts and restructuring under recent administrative reforms. Those changes have created review backlogs across multiple divisions, affecting other ALS programs as well, the company says , adding that earlier this year Coya Therapeutics also faced an FDA IND delay on its ALS drug COYA-302 due to internal workload pressures.

“This delay is extremely disappointing — particularly given the straightforward nature of the information provided in our response,” said Neurizon CEO Michael Thurn. “We remain confident in the potential of NUZ-001 as a transformative therapy for ALS and are working with U.S. experts and patient groups to advocate for an expedited review.”

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