Biologics

Emergent Bio Wins Mpox Vaccine Approval

FDA has approved an Emergent BioSolutions supplemental BLA for an expanded indication for ACAM2000, (smallpox and mpox vaccine, live) to include preventing mpox disease in individuals determined to be at high risk for mpox infection. The approval is based on previously available data showing that ACAM2000 is effective in protecting against mpox virus exposure, according to the company. The single-dose vaccine is administered percutaneously via a bifurcated needle that is dipped into the vaccine and the skin is then pricked several times in the upper arm.

The vaccine was originally approved by FDA in 2007 for the prevention of smallpox disease in individuals at high risk, the company says. Mpox (also known as monkeypox) is an infectious disease endemic to central and west Africa caused by the double-stranded DNA mpox virus, the company says. “The virus is a member of the Orthopoxvirus genus in the Poxviridae family, and related to the virus which caused smallpox, which was eradicated in 1980."

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