Biologics

GSK’s Arexvy RSV Vaccine for High-Risk Adults Ages 18–49

FDA has expanded the approved use of GSK’s Arexvy, a respiratory syncytial virus (RSV) vaccine that now includes the in adults aged 18 to 49 who are at increased risk of severe disease. The vaccine was previously authorized for preventing RSV-related lower respiratory tract disease (LRTD) in adults aged 60 and older, as well as adults aged 50 to 59 with risk factors for severe illness. The new approval broadens access to younger adults with underlying medical conditions that elevate their risk of complications from RSV infection.

According to GSK, an estimated 21 million adults in the U.S. under age 50 have at least one condition that increases their risk of severe RSV disease.

FDA’s decision was supported by data from a Phase 3b clinical trial that evaluated immune responses in adults aged 18–49 with stable chronic illnesses that increase the risk of RSV-related complications. The study enrolled more than 1,400 participants across 52 sites in six countries, the company says.

Researchers found the vaccine generated an immune response in the younger high-risk group that was non-inferior to that observed in adults aged 60 and older, a population in which vaccine efficacy had already been demonstrated in earlier Phase 3 trials.

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

Read more

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