News Service

late-breaking news in healthcare

FDA News Briefs for Monday, March 27, 2017

March 27, 2017 News Service

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

FDA Updates Information on Breast Implant-Associated Anaplastic Large Cell Lymphoma

March 24, 2017 News Service

Women with breast implants have a very low but increased risk for developing a unique type of non-Hodgkin's lymphoma, according to the Food and Drug Administration (FDA).

FDA Approves Xadago As Add-On Therapy for Parkinson’s Disease

March 23, 2017 News Service

On March 21, 2017, the Food and Drug Administration (FDA) approved Xadago (safinamide; Newron Pharmaceuticals.) as an adjunctive therapy for patients with Parkinson’s disease (PD) who are taking levodopa/carbidopa and experiencing “off” episodes when that primary therapy is not working well.  

ASCO Issues Global Guidelines for HPV Vaccination for Cervical Cancer Prevention

March 22, 2017 News Service

The American Society of Clinical Oncology (ASCO) has issued the first guideline on human papillomavirus (HPV) vaccination for the primary prevention of cervical that is intended for clinicians worldwide.

Repatha Added to Statins Cuts Cardiovascular Risk

March 21, 2017 News Service

Results of the FOURIER trial, published last week in the New England Journal of Medicine, suggest that the addition of Repatha (evolocumab; Amgen Inc.) to a statin regimen may reduce the risk of major adverse cardiovascular events, but has no effect on cardiovascular mortality.

FDA News Briefs for Monday, March 20, 2017

March 20, 2017 News Service

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

FDA Approves a New Indication for Keytruda

March 17, 2017 News Service

On March 14, 2017, the Food and Drug Administration (FDA) granted accelerated approval to Keytruda (pembrolizumab; Merck and Co. Inc.) for a new indication. The programmed death receptor-1 (PD-1) inhibitor is now indicated to treat adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or those whose disease has relapsed after three or more prior lines of therapy.

FDA Announces Recall of SynchroMed Implantable Infusion Pumps

March 16, 2017 News Service

On March 14, 2017, the Food and Drug Administration (FDA) announced a Class I recall of SynchroMed Implantable Infusion Pumps (Medtronic Inc.) due to a software problem that may cause unintended delivery of drugs.

FDA Approves New First-Line Oral Treatment for Advanced Breast Cancer

March 15, 2017 News Service

The Food and Drug Administration (FDA) has approved Kisqali (Ribociclib; Novartis Pharmaceuticals Corp.) for frontline treatment of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer. Kisqali is indicated for use in combination with an aromatase inhibitor.

U.S. Professional Societies Release First Guidelines on Syncope

March 14, 2017 News Service

The American College of Cardiology, the American Heart Association, and the Heart Rhythm Society have issued the first U.S. guidelines on the management of adult and pediatric patients with suspected syncope (fainting). The new guidelines were developed in collaboration with the American College of Emergency Physicians and the Society for Academic Emergency Medicine, and are endorsed by the Pediatric and Congenital Electrophysiology Society.