News Service

late-breaking news in healthcare

FDA News Briefs for Thursday, May 24, 2018

May 24, 2018 News Service

These Food and Drug Administration (FDA) developments came in this week.

Class I Recall: HeartMate 3 Left Ventricular Assist System

May 23, 2018 News Service

Abbott has issued a recall of its HeartMate 3 Left Ventricular Assist System (LVAS) due to a malfunction in the device’s outflow graft assembly that may cause graft occlusion over time. Yesterday, the Food and Drug Administration (FDA) identified the recall as Class I—the most serious type of recall—because of the risk for serious injury or death.

FDA Approves Doptelet

May 22, 2018 News Service

The Food and Drug Administration (FDA) has approved Doptelet (avatrombopag; AkaRx Inc.) for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure. This is the first drug approved by the FDA for this use. 

FDA News Briefs for Monday, May 21, 2018

May 21, 2018 News Service

These Food and Drug Administration (FDA) developments came in late last week.

FDA News Briefs for Friday, May 18, 2018

May 18, 2018 News Service

These Food and Drug Administration (FDA) developments came in this week.

FDA Approves First Epoetin Alfa Biosimilar for Sale in U.S.

May 17, 2018 News Service

The Food and Drug Administration (FDA) on Tuesday approved Retacrit (epoetin alfa-epbx; Pfizer) as a biosimilar to Epogen/Procrit (epoetin alfa). Retacrit is now the first epoetin alfa biosimilar approved for sale in the United States.

FDA News Briefs for Tuesday, May 15, 2018

May 15, 2018 News Service

These Food and Drug Administration (FDA) developments came in last week.

USPSTF Updates Recommendations on Prostate Cancer Screening

May 14, 2018 News Service

The U.S. Preventive Services Task Force (USPSTF) has issued a final recommendation statement on screening for prostate cancer.

FDA Safety Alerts for Friday May 11, 2018

May 11, 2018 News Service

These Food and Drug Administration (FDA) Safety Alerts were recently issued.

FDA News Briefs for Thursday, May 10, 2018

May 10, 2018 News Service

These Food and Drug Administration (FDA) developments came in this week.