Biologics

FDA Approves Jynneos Smallpox and Monkeypox Vaccine

FDA has approved Bavarian Nordic A/S’s Jynneos smallpox and monkeypox vaccine, live, non-replicating, who are determined to be at high risk for smallpox or monkeypox infection. It is the only FDA-approved vaccine for preventing monkeypox disease.

The agency says that Jynneos will be available for those determined to be at high risk of either smallpox or monkeypox infection. It is also part of the Strategic National Stockpile, the nation’s largest supply of potentially life-saving pharmaceuticals and medical supplies for use in a public health emergency that is severe enough to cause depletion of local supplies.

Jynneos’ safety was assessed in more than 7,800 individuals who received at least one dose of the vaccine. The most commonly reported side effects were pain, redness, swelling, itching, firmness at the injection site, muscle pain, headache, and fatigue. FDA says no safety concerns that would require a Medication Guide have been identified for Jynneos. It is administered in two doses given four weeks apart.

FDA gave the application priority review and with the approval issued a material threat medical countermeasure priority review voucher to Bavarian Nordic.

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