November 21, 2023

On November 20, 2023, the U.S. Food and Drug Administration (FDA) alerted healthcare providers and facilities not to use Cardinal Health Monoject syringes with syringe pumps and patient-controlled analgesia (PCA) pumps while the agency further evaluates a reported issue. FDA classified it as a class I recall, the most serious type of recall, where use of the product or device may result in serious injury or death.

November 21, 2023

Located on chromosome 2 with 11 exons, BRCA1-associated ring domain (BARD1) is part of the BRCA1/BARD1 protein complex and associated with breast cancer susceptibility. The protein complex enhances ubiquitin ligase activity, which helps regulate centrosome function, repair DNA, and regulate cell cycles to maintain genetic stability. BARD1 interacts with and stabilizes BRCA1 in the repair of double-strand DNA breaks as part of the homologous recombination pathway.

November 20, 2023

On November 17, 2023, the U.S. Food and Drug Administration (FDA) announced that B. Braun Medical, Inc., is recalling its Infusomat Space Volumetric Infusion Pump System because of faulty occlusion alarms, causing the pump to stop delivering medications, including high-risk medications such as vasopressors. Interrupting the infusion of high-risk medications may lead to hemodynamic instability, which may be life-threatening or lead to death in some cases. FDA is aware of 51 reports, one injury, and one death related to the recall.

November 16, 2023

On November 16, 2023, the U.S. Food and Drug Administration (FDA) approved capivasertib (Truqap™) with fulvestrant for adult patients with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1, or PTEN alterations, as detected by an FDA-approved test, following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.

November 15, 2023

On November 15, 2023, the U.S. Food and Drug Administration (FDA) approved repotrectinib (Augtyro™) for locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). This is the first FDA approval for treatment of patients with ROS1-positive NSCLC who have previously received a ROS1 tyrosine kinase inhibitor (TKI), in addition to patients who are TKI naïve.