Drugs

FDA Review of Govorestat on Track: Company

Applied Therapeutics says that following a late-cycle review meeting with FDA on the company’s NDA for govorestat to treat classic galactosemia, the agency no longer sees a need for a 10/2024 advisory committee meeting that had been scheduled and is moving forward with its priority review toward the PDUFA action date of 11/28. Company CEO Shoshana Shendelman says Applied Therapeutics is “incredibly pleased by the ongoing collaborative dialog with FDA during the NDA review process and we look forward to continuing to work together with the agency to bring the first potential treatment to classic galactosemia patients.”

Govorestat is described as a central nervous system penetrant aldose reductase inhibitor that is being developed to treat several rare neurological diseases. FDA has given it orphan drug designation to treat several diseases, pediatric rare disease designation for galactosemia and PMM2-CDG (congenital disorder of glycosylation), and fast-track designation for galactosemia.

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