Drugs

Clinical Hold on AZ Blood Cancer Drug

FDA has placed a clinical hold on an AstraZeneca clinical trial of its investigational blood cancer drug AZD5991. Fierce Biotech reports the company had already put a hold on the trial after heart issues were found in one patient being treated with the drug.

AZ told the online newsletter that an asymptomatic elevation in cardiovascular laboratory parameters occurred among the patient group receiving AZD5991 in combination with AbbVie/Roche’s venetoclax (Venclexta) FDA-approved blood cancer medicine. The cardiovascular issue was not seen in patients receiving AZD5991 as monotherapy, it said.

A company spokesperson told the newsletter the “asymptomatic elevation has since been resolved. We are now in the process of conducting a full analysis of the study data and working closely with FDA for the benefit of the patients.”

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