Tag Archive for: patient safety

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.

The company announced that it will not sell new devices to treat sleep apnea in the United States in the coming years as it works to comply with a settlement with the Food and Drug Administration.

The FDA’s Peter Marks and Nicole Verdun in the NEJM Wednesday disclosed that more than 27,000 CAR-T doses have been administered in the U.S. as of the end of 2023, of which there are 22 cases of T-cell cancers.

Citing America’s Poison Centers, which represents 55 regional poison centers across the U.S., Reuters revealed that all three incidences of hypoglycemia were detected by the same regional poison control center and that the FDA was investigating these reports.

The agency stated that companies will be required to add a serious warning on the prescribing information for cancer therapies known as CAR-T, made by Gilead Sciences, Johnson & Johnson, Novartis and others.

The regulator concluded that Prolia (denosumab) increases the risk of severe hypocalcemia, which may result in hospitalization and could trigger life-threatening events or even lead to death.

The European Union’s drug regulator will this week consider wider use of Novo Nordisk’s weight-loss drug Wegovy to include reducing the risk of strokes and heart attacks.

The current unmet needs in the female contraceptives market are similar to those that were present 10 years ago, according to GlobalData.

In its announcement, the Boston, MA–based company said that the deaths were “unrelated” to the study treatment and that the study pause was “protocol-specified.”