Drugs

FDA Grants Priority Review to J&J’s Akeega sNDA

FDA has accepted for priority review a Johnson & Johnson supplemental NDA for Akeega (niraparib and abiraterone acetate dual-action tablet) plus prednisone for treating BRCA-mutated metastatic castration-sensitive prostate cancer. If approved, the company says the regimen would become the first PARP-based precision medicine combination for this patient population, addressing a major unmet need among men with BRCA-mutated prostate cancer — a group known to experience faster disease progression and poorer outcomes than those without the mutation.

The submission is supported by data from the Phase 3 AMPLITUDE trial, which showed that Akeega plus prednisone reduced the risk of radiographic progression or death by 48% compared with abiraterone plus prednisone alone, according to J&J. The combination also prolonged time to symptomatic progression by 56% and showed a favorable trend toward overall survival improvement, with a 25% reduction in the risk of death, it adds

Akeega was approved in 2023 for BRCA-mutated metastatic castration-resistant prostate cancer.

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