Drugs

Clinical Hold Lifted on Gilead’s Magrolimab

FDA has lifted a Gilead Sciences partial clinical hold earlier placed on studies evaluating its investigational agent magrolimab in combination with azacytidine in myelodysplastic syndrome and acute myeloid leukemia patients. The agency removed the hold after reviewing the comprehensive safety data from each trial, according to the company.

Gilead says it is still working with FDA regarding the remaining partial hold affecting studies evaluating magrolimab in diffuse large B-cell lymphoma and multiple myeloma. Ongoing studies evaluating magrolimab in solid tumors were not subject to the hold.

During the partial hold, patients already enrolled in the affected Gilead magrolimab studies continued receiving treatment. Gilead says it is confident the readout for the first interim analysis remains on schedule for 2023.

Magrolimab is described by Gilead as a potential, first-in-class investigational monoclonal antibody against CD47 and a macrophage checkpoint inhibitor that is designed to interfere with recognition of CD47 by the SIRPa receptor on macrophages.

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

Read more

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