Biologics

Evive Bio BLA for Neutropenia Therapy

Evive Biotech has submitted a BLA for Ryzneuta (also known as F-627), indicated for treating chemotherapy-induced neutropenia. Neutropenia is a common chemo side-effect that is characterized by low levels of neutrophils, a type of white blood cell that fights infection, according to the company. It says Ryzneuta strengthens the immune system’s ability to fight infection by increasing the production of these white blood cells, thus preventing potential chemotherapy dose reductions and delays that may compromise treatment outcomes.

The submission is based on data from 10 clinical trials that enrolled over 1,200 patients to date in multiple territories including the U.S., EU, Australia, and China. Ryzneuta’s pivotal Phase 3 trial was conducted under a Special Protocol Assessment in agreement with FDA, Evive says.

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