Drugs

Complete Response on F2G Antifungal NDA

FDA has issued F2G Ltd. a complete response letter on its NDA for olorofim, an antifungal for invasive fungal infections in patients who have limited or no treatment options. The letter requested additional data and analyses before it can approve the submission, according to the company. “The FDA encouraged the company to work with the agency to plan for the new analyses and develop the NDA package,” it says.

F2G says the original NDA contained data from the first 100 patients enrolled in the then-ongoing Phase 2b single-arm, open-label study (Study 32, NCT03583164). Since then, Study 32 has now completed enrollment with a total of 203 patients, and the full data set will now be submitted as part of the revised NDA package, it adds. “To expand on the studied patient population,” it continues, “F2G has initiated a global Phase 3 trial (OASIS) to compare treatment with olorofim versus AmBisome followed by standard of care in patients with proven or probable invasive fungal infection due to Aspergillus species (NCT05101187).”

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