Drugs

FDA Fast Track for eFFECTOR’s Zotatifin

FDA has granted fast-track designation to eFFECTOR Therapeutics for its zotatifin in combination with fulvestrant and abemaciclib (ZFA triplet) to treat ER+/HER2- advanced metastatic breast cancer. The company says the designation covers the use of ZFA triplet for second- or third-line treatment of adult patients with disease progression following treatment with endocrine therapy and a CDK 4/6 inhibitor.

Zotatifin is described as a “potent and sequence-selective small molecule inhibitor of the RNA helicase eIF4A that is designed to suppress the expression of a network of cancer-driving proteins, including Cyclins D and E, CDKs 2, 4, and 6 and select RTKs as well as KRAS.” It is currently being evaluated in an ongoing clinical trial in patients with ER+/HER2- metastatic breast 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