The Food and Drug Administration (FDA) has approved Nexletol (bempedoic acid; Esperion) as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of low-density lipoprotein cholesterol (LDL-C). Nexletol is a first-in-class adenosine triphosphate-citrate lyase (ACL)…
Compliance with Food and Drug Administration Amendments Act of 2007 low, not improving.
The primary end point was radiographic progression-free survival (rPFS), defined as the time from randomization to radiographic disease progression at any time or death within 24 weeks after drug discontinuation.
Some lots of losartan contaminated with the cancer-causing chemical N-methylnitrosobutyric acid
Proportion of apical procedures using transvaginal mesh decreased in year after safety communication
The FDA has concluded that the use of entacapone to treat Parkinson disease (PD) does not increase the risk of developing prostate cancer.
The agency alleges manufacturers failed to provide evidence of the long-term safety of surgical mesh for transvaginal repair of anterior compartment prolapse.
Investigation triggered by meta-analysis showing possible increased mortality in PAD patients at 2 years
Agency cannot accept new fees or applications until the shutdown is over
Patients at risk include those with hypertension or certain genetic disorders and the elderly