Drugs

Celcuity NDA Gets Priority Review for Breast Cancer

FDA has accepted for priority review a Celcuity NDA for gedatolisib in patients with hormone receptor–positive, HER2-negative, PIK3CA wild-type advanced breast cancer. The company says the submission is based on data from the PIK3CA wild-type cohort of Celcuity’s Phase 3 VIKTORIA-1 trial, which evaluated gedatolisib in patients with advanced breast cancer. The agency has set a 7/17 user fee review action target date.

Gedatolisib is described as an investigational inhibitor designed to block multiple components of the PI3K/AKT/mTOR signaling pathway, a critical driver of tumor growth and resistance in many cancers. Unlike approved therapies that target single elements of the pathway, the drug is intended to provide more comprehensive suppression, which Celcuity says may help overcome adaptive resistance mechanisms.

Gedatolisib has previously received Breakthrough Therapy and Fast Track designations based on early clinical evidence suggesting meaningful benefit.

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