UPLIZNA Offers gMG Patients Deep and Durable Symptom Control and Twice-Yearly Dosing* First and Only CD19-Targeted B Cell Therapy Approved in anti-AChR and anti-MuSK ...
The U.S. Food and Drug Administration has issued a recall of glucose monitors used by those with diabetes for malfunctioning.
The application is based on data from multiple subcutaneous (SC) administration sub-studies of lecanemab conducted as part of the Phase 3 Clarity AD open-label extension (OLE), following the 18-month ...
Hormone therapies for menopause will no longer carry a black box warning about serious risks such as breast cancer, heart attack and stroke, the Food and Drug Administration announced Monday. In the ...
Studies in the early 2000s claimed there were major risks associated with HRT. The Food and Drug Administration said Monday it will remove the "black box" warning from hormone replacement therapy (HRT ...
Having exhibited her proficiency through diverse and complex characters, Sydney Sweeney has established herself as a high-profile Hollywood actress. With Sweeney’s value in the entertainment industry ...
Tylenol maker Kenvue is calling on the Food and Drug Administration (FDA) to back off a proposed safety label change to acetaminophen after the Trump administration linked its use during pregnancy to ...
Kenvue, the American company that makes Tylenol, says the US Food and Drug Administration should not make proposed changes to the product’s safety label to reflect research about a possible connection ...
The FDA last overhauled its Nutrition Facts label in 2016. Now, a decade later, new food and beverage label changes are expected to roll out. What’s on your label? It may be changing soon. The Food ...
The FDA has adjusted the label of Johnson & Johnson and Legend Biotech’s Carvykti, warning patients and doctors that use of the multiple myeloma treatment could increase the risk of an intestinal ...
The FDA has expanded its Early Alert program to give the healthcare industry earlier visibility into potential high-risk medical device issues. The agency’s Center for Devices and Radiological Health ...