Drugs

FDA Accepts for Review Saol Therapeutics’ SL1009 NDA Resubmission

FDA has accepted for review a Saol Therapeutics NDA resubmission for SL1009 (sodium dichloroacetate, or DCA), an investigational treatment for pyruvate dehydrogenase complex deficiency (PDCD), a rare and life-threatening mitochondrial disorder with no currently approved therapies. The agency has set a user fee review action target date of 12/30.

The resubmission follows additional analyses requested by FDA after the agency issued a Complete Response Letter (CRL) in 8/2025, according to the company. Saol says the CRL did not identify concerns related to the product’s safety profile or manufacturing, but instead requested additional evidence supporting the application.

When the company first received the CRL, it said it would “take several years and require significant financial resources” to address the deficiencies as FDA requested.” However, it says it was able to address FDA’s concerns through analyses of existing data, including survival outcomes, functional measures, mechanistic evidence, and long-term safety information, allowing it to resubmit the application without conducting an additional clinical trial.

Saol notes the path forward was established through discussions with FDA during a Type A meeting in December 2025 and a Type C meeting in March. During those meetings, the agency recommended additional survival analyses to support the NDA.

PDCD is described as a genetic disorder caused by defects in the pyruvate dehydrogenase complex, a critical cellular pathway involved in converting nutrients into energy. The disease can lead to chronic energy deficits, lactic acidosis, developmental impairment, neurological complications, and early childhood death.

SL1009 is designed to target the underlying metabolic dysfunction associated with the disease and would be administered with a proprietary dose-determining genetic test intended to identify patients most likely to benefit from treatment, according to the company.

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

Read more

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