Drugs

Telix sNDA Approved for Illuccix Selection

FDA has approved a Telix Pharmaceuticals supplemental NDA for Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) for use in selecting patients with metastatic prostate cancer for whom Novartis’ Pluvicto is indicated. To qualify to be treated with the prostate-specific membrane antigen (PSMA)-directed radioligand Pluvicto, patients must be imaged with an approved gallium-based PSMA-PET agent such as Illuccix, Telix says.

Approval was based on data from the VISION Phase 3 study that demonstrated Illuccix “helped doctors detect prostate cancer and identify the appropriate patients for PSMA-based radioligand therapy,” Telix )says. About 32,000 patients per year in the U.S. may be considered for PSMA-directed radioligand therapy, it adds.

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