FDA News

FDA Could Green-Light COVID-19 Vaccines Before Clinical Trials Completed

Publish Date September 4, 2020

Data, not politics, would guide any FDA decision on vaccines, according to agency commissioner.

FDA Approves First-in-Class Cholesterol Lowering Therapy

Publish Date February 25, 2020

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)…

Fewer Than Half of Clinical Trials Comply With Reporting Laws

Publish Date January 23, 2020

Compliance with Food and Drug Administration Amendments Act of 2007 low, not improving.

FDA Expands Indication for Xtandi to Treat Metastatic Castration-Sensitive Prostate Cancer

Publish Date December 17, 2019

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.

More Blood Pressure Drugs Recalled

Publish Date September 26, 2019

Some lots of losartan contaminated with the cancer-causing chemical N-methylnitrosobutyric acid

2011 FDA Safety Message Tied to Drop in Transvaginal Mesh Use

Publish Date September 13, 2019

Proportion of apical procedures using transvaginal mesh decreased in year after safety communication

FDA: Entacapone Not Associated With Increased Prostate Cancer Risk

Publish Date September 4, 2019

The FDA has concluded that the use of entacapone to treat Parkinson disease (PD) does not increase the risk of developing prostate cancer.

FDA Pulls Surgical Mesh for Pelvic Organ Prolapse From the Market

Publish Date April 16, 2019

The agency alleges manufacturers failed to provide evidence of the long-term safety of surgical mesh for transvaginal repair of anterior compartment prolapse.

FDA Investigating Paclitaxel Balloons and Stents

Publish Date January 22, 2019

Investigation triggered by meta-analysis showing possible increased mortality in PAD patients at 2 years

FDA Down to 5 Weeks of Funding to Review New Drug Applications

Publish Date January 21, 2019

Agency cannot accept new fees or applications until the shutdown is over