Following a months-long safety review, the regulator said it is now requiring black box warnings for all commercially available CAR-T therapies to reflect the risk of secondary malignancies.
Tag Archive for: patient safety
The World Health Organization is likely to issue a wider warning about contaminated Johnson and Johnson-made children’s cough syrup found in Nigeria last week, it said in an email.
The batch recalled was made by J&J in South Africa in May 2021 but Kenvue now owns the Benylin Paediatric syrup brand after a spin-off from J&J last year.
A U.S. lawmaker involved in health policy has asked the Food and Drug Administration why it did not inspect Elon Musk’s Neuralink before allowing the brain implant company to test its device in humans.
The health regulator said these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated through new or updated device labeling.
Yesterday the agency classified the recall of privately held Vyaire Medical’s respiratory support devices as most serious and said their use could cause major injuries or death.
In a briefing document for Thursday’s advisory committee meeting, the FDA pointed to efficacy and safety issues with Geron’s New Drug Application for imetelstat in myelodysplastic syndromes.
Staff reviewers said that the pattern of early deaths observed in patients treated with both the therapies in their respective trials raised uncertainty about the treatments’ overall survival benefit in patients.
The injectable drug imetelstat was being studied in patients with lower risk myelodysplastic syndromes (MDS), a type of blood cancer, which requires frequent blood transfusions for managing anemia.
Challenges transitioning new clinicians from academic training to professional practice tops ECRI’s 2024 list of top 10 patient safety concerns for 2024 released by one of the nation’s largest patient safety organizations. ECRI researchers compiled the report by drawing on evidence-based research, data, and expert insights.
