News Service

late-breaking news in healthcare

FDA Approves First Treatment for Very Rare Enzyme Disorder

November 17, 2017 News Service

The Food and Drug Administration (FDA) has approved Mepsevii (vestronidase alfa-vjbk; Ultragenyx Pharmaceutical, Inc.), the first therapy indicated to treat mucopolysaccharidosis type VII (MPS VII), a serious genetic condition that affects less than 150 patients worldwide.

New ACC/AHA Guidelines Lower Threshold for Hypertension

November 16, 2017 News Service

The American College of Cardiology (ACC) and the American Heart Association (AHA) have released new Clinical Practice Guidelines on hypertension that lower the criteria for treatable high blood pressure (BP) from ≥ 140/90 mm Hg to ≥ 130 mm Hg for the top (systolic) number or ≥ 80 mm Hg for bottom (diastolic) number.

FDA Approves First Digital Pill

November 15, 2017 News Service

The Food and Drug Administration (FDA) has approved Abilify MyCite (aripiprazole tablets with sensor; Otsuka Pharmaceutical Co. and Proteus Digital Health), the first digital pill with an ingestion tracking system.

FDA Expands Indications for Schizophrenia Drug

November 14, 2017 News Service

The Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Vraylar (cariprazine; Allergan), an orally administered atypical antipsychotic agent.

FDA News Briefs for Monday, November 13, 2017

November 13, 2017 News Service

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

FDA Approves Prevymis to Prevent CMV Following Bone Marrow Transplant

November 10, 2017 News Service

On November 8, 2017, the Food and Drug Administration (FDA) approved Prevymis (letermovir; Merck) tablets and injection for the prevention of cytomegalovirus infection in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant.

FDA News Briefs for Thursday, November 9, 2017

November 9, 2017 News Service

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

Zelboraf Now Indicated for Erdheim-Chester Disease

November 8, 2017 News Service

The Food and Drug Administration has approved the first treatment for Erdheim-Chester Disease, a rare type of slow-growing blood cancer that affects 600 to 700 patients worldwide.  

ORBITA Trial Raises Questions about Benefit of Stents in Stable Angina

November 7, 2017 News Service

A study published in the Lancet last week found that insertion of a drug-eluting coronary stent was no better than placebo in increasing exercise tolerance in patients with medically treated angina and significant coronary stenosis. This is the first published placebo-controlled trial evaluating coronary stents for stable angina.

FDA News Briefs for Monday, November 6, 2017

November 6, 2017 News Service

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