Biologics

EUA Revised to Limit Convalescent Plasma Use

FDA is limiting the emergency use authorization (EUA) for Covid-19 convalescent plasma after evaluating the most recent information available. “Based upon data from new clinical trials analyzed or reported since the original EUA was issued in August 2020, we have revised the EUA to limit the authorization to the use of high titer Covid-19 convalescent plasma for the treatment of hospitalized patients early in the disease course,” an FDA notice says. It also limits its use to those hospitalized patients who have impaired humoral immunity and cannot produce an adequate antibody response. “Plasma with low levels of antibodies has not been shown to be helpful in Covid-19,” FDA notes.

The agency also says that the use of low titer Covid-19 convalescent plasma is no longer authorized under the EUA as additional data from clinical trials have not shown evidence to demonstrate that it may be effective in treating hospitalized patients. Additionally, the EUA has been updated to include several additional tests to be used in manufacturing convalescent plasma, such as testing plasma donations for anti-SARS-CoV-2 antibodies as a manufacturing step to determine suitability before release.

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