FDA News

Nirsevimab, a long-acting monoclonal antibody, if approved, will be indicated to prevent RSV LRTD in neonates and infants born during or entering into their first RSV season.

Proposed indications for the investigational factor XIa inhibitor are: stroke prevention after acute ischemic stroke or high-risk transient ischemic attack; recent acute coronary syndrome; and atrial fibrillation.

Compounded versions of semaglutide, often sold online, may contain salt versions of the molecule and are not evaluated by the FDA for safety or efficacy.

The FDA's decision was based on data from the pivotal phase 3 RENOIR trial, which demonstrated the efficacy, immunogenicity, and safety of Abrysvo in adults aged ≥60 years.

The FDA approved Paxlovid™ for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe disease.

The novel co-inhibitor of sodium glucose cotransporter-1/2 proteins will be available by the end of June 2023, according to Lexicon Pharmaceuticals.

Your daily dose of clinical news you may have missed.

Bayer's investigational FXIa inhibitor is currently being studied in a large-scale phase 3 development program expected to enroll more than 27 000 participants.

Brixadi is the first and only long-acting buprenorphine injectable that is available in both weekly and monthly doses.

Medical director of the NFID William Schaffner, MD, discusses the research behind the FDA's decision to approve the first-ever RSV vaccine.