Biologics

FDA OKs Pfizer Abrysvo RSV Vaccine

FDA has approved Pfizer’s Abrysvo (respiratory syncytial virus vaccine), a bivalent RSV (respiratory syncytial virus) prefusion F vaccine, to prevent lower respiratory tract diseases caused by RSV in people age 60 and older. A company statement says Abrysvo is unadjuvanted and is composed of two preF proteins selected to optimize protection against RSV A and B strains. The vaccine was observed to be safe and effective, Pfizer says.

The approval is based on data from the global pivotal Phase 3 RENOIR study in some 37,000 older adults.

FDA granted Abrysvo breakthrough therapy designation on 3/24/22. The agency accepted Pfizer’s BLA for Abrysvo for priority review in 11/2022.

FDA has also granted priority review for a Pfizer application for an indication to prevent lower respiratory tract and severe lower respiratory tract diseases caused by RSV in infants from birth to six months of age by active immunization of pregnant women. The FDA Vaccines and Related Biological Products Advisory Committee voted in May that available data support the efficacy and safety of the maternal indication. The agency has set a PDUFA action date for that indication in August.

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