Drugs

FDA Tightens Pemgarda Covid-19 EUA

FDA approved 8/23 changes, including a limitation on authorized use, to the terms of the emergency use authorization for Invivyd’s Pemgarda (pemivibart) injection indicated for pre-exposure prophylaxis of Covid-19. An agency memo lists these changes and the rationale for them:

include Pemgarda pseudotyped virus-like particle neutralization activity data against recent and currently circulating SARS-CoV-2 variants;
indicate the risk of Covid-19 due to SARS-CoV-2 variants with substantially reduced susceptibility to Pemgarda;
add a limitation of authorized use for SARS-CoV-2 variants with substantially reduced susceptibility to Pemgarda;
remove specific authentic virus neutralization data deemed no longer viable based on new information obtained from the sponsor;
update immunobridging results; and
add exploratory clinical efficacy results from the CANOPY trial.

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