Tag Archive for: patient safety

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.

The FDA and CDC warned Thursday of a small increased risk of developing Guillain-Barré syndrome in older adults after immunization with respiratory syncytial virus vaccines from GSK and Pfizer.

The U.S. drug regulator is set to increase the number of inspections at Indian drug manufacturing units in 2024 amid growing concerns over the quality of drugs, according to reports.

The FDA stated that it has not authorized, cleared, or approved any smartwatch or smart ring that is intended to measure or estimate blood glucose values on its own.

Rapt Therapeutics said on Tuesday the U.S. FDA had placed on hold two mid-stage trials of the company’s drug to treat eczema and asthma, after liver failure was observed in one of the patients.

Animal and early-stage human trial data for Amgen’s experimental obesity drug published in a medical journal showed that it promoted significant weight loss with an acceptable safety profile, the company said on Monday.