Drugs

Fast Track Awarded to Polycythemia Vera Drug

FDA has granted Italfarmaco a fast track designation to givinostat for treating patients with polycythemia vera (PV), a rare hematologic cancer. Givinostat is an orally administered histone deacetylase inhibitor (HDACi)with potential applications in both neuromuscular disorders and oncology, according to the company. “HDACis work by modulating key cellular pathways that regulate gene expression, offering promising therapeutic benefits across a range of diseases,” it says.

PV is described by the company as a rare blood cancer characterized by the overproduction of erythroid, myeloid, and megakaryocytic components in the bone marrow. PV commonly causes symptoms like headache, weakness, and itching, with severe complications including stroke, heart attack, and deep vein thrombosis, and there is the risk of progression to myelofibrosis or acute myeloid leukemia.

Givinostat is designed to target and modulate abnormal gene expression, such as excessive cell proliferation driven by mutations (JAK2V617F) commonly found in PV patients. It is currently being evaluated in a Phase 3 trial (NCT06093672) in Europe, the UK, Israel, and North America.

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