News Service

late-breaking news in healthcare

FDA Approves Kevzara for Treatment of Rheumatoid Arthritis

May 26, 2017 News Service

The Food and Drug Administration (FDA) has approved Kevzara (sarilumab; Regeneron and Sanofi) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to 1 or more disease-modifying antirheumatic drugs (DMARDs).

FDA Approves Keytruda for Any Advanced Solid Cancer With A Specific Genetic Biomarker

May 25, 2017 News Service

The Food and Drug Administration (FDA) has granted an accelerated approval to Keytruda (pembrolizumab; Merck) for the treatment of any advanced microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid malignant tumor that has progressed following prior treatment.

FDA Announces Class I Recall of V60 Ventilator

May 24, 2017 News Service

Respironics California, LLC recently recalled 20,690 Philips V60 Non-Invasive Ventilators due to faulty cable pins that may cause the device to unexpectedly shut down.

FDA Approves Actemra for Treatment of Giant Cell Arteritis

May 23, 2017 News Service

On May 22, 2017, the Food and Drug Administration (FDA) expanded the approved use of Actemra (tocilizumab; Genentech Inc.) to include treatment of adults with giant cell arteritis. This is the first FDA-approved treatment specifically for giant cell arteritis.

FDA News Briefs for Monday, May 22, 2017

May 22, 2017 News Service

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

USPSTF Continues to Recommend Against Menopausal HRT for Prevention of Chronic Conditions

May 19, 2017 News Service

The U.S. Preventive Services Task Force (USPSTF) has updated its 2012 recommendation statement on menopausal hormone replacement therapy for the prevention of chronic conditions.

Boxed Warning of Amputation Risk Added to Canagliflozin Drug Labels

May 18, 2017 News Service

The Food and Drug Administration (FDA) confirmed on Tuesday that the type 2 diabetes drugs Invokana, Invokamet, and Invokamet XR (canagliflozin; Janssen Pharmaceuticals Inc.) increase risk for leg and foot amputations.

Abbott Vascular Recalls Three Coronary Catheters

May 17, 2017 News Service

Abbott Vascular has initiated a voluntary recall of certain lots of the NC Trek RX Coronary Dilatation Catheter, NC Traveler Coronary Dilatation Catheter, and NC Tenku RX PTCA Balloon Catheter due to reports of difficulty in removing the protective balloon sheath, which could cause problems with inflating or deflating the balloon.

CDC Releases New Recommendations on Use of Cholera Vaccine

May 16, 2017 News Service

  The Centers for Disease Control and Prevention (CDC) has released new recommendations for the use of Vaxchora (CVD 103-HgR; PaxVax), the only Food and Drug Administration (FDA)-approved cholera vaccine.  

FDA News Briefs for Monday, May 15, 2017

May 15, 2017 News Service

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