Drugs

Unicycive Plans OLC NDA Resubmission This Year

Unicycive says that after discussions with FDA and the company’s third-party manufacturing vendor, it plans to resubmit its NDA for oxylanthanum carbonate (OLC) to FDA before the end of 2025. FDA had issued a 6/30 complete response letter (CRL) citing concerns about the compliance status of Unicycive’s third-party manufacturing vendor and no other issues.

“We are grateful for the highly constructive feedback and detailed meeting minutes we received from FDA and look forward to resubmitting the NDA as we advance OLC toward potential approval,” Unicycive CEO Shalabh Gupta said in a statement. “Following our interactions with FDA, we are very encouraged about the potential for a swift resolution of the issue raised in our CRL, and we believe we are now on track to resubmit our NDA before the end of the year, which could lead to a PDUFA date in the first half of 2026.”

OLC is described as an investigational oral phosphate binder that leverages proprietary nanoparticle technology to deliver high phosphate-binding potency, reducing the number and size of pills that patients must take to treat hyperphosphatemia in patients with chronic kidney disease on dialysis. The company says it is seeking 505(b)(2) approval based on data from three clinical studies.

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