News Service

late-breaking news in healthcare

FDA News Briefs for Monday, July 16, 2018

July 16, 2018 News Service

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

FDA News Briefs for Friday, July 13, 2018

July 13, 2018 News Service

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

FDA News Briefs for Thursday, July 12, 2018

July 12, 2018 News Service

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

USPSTF Issues Recommendations on Risk Assessment for Cardiovascular Disease

July 11, 2018 News Service

The U.S. Preventive Services Task Force (USPSTF) issued 2 final Recommendation Statements on Tuesday; both related to risk assessment for cardiovascular disease.

FDA News Briefs for Monday, July 9, 2018

July 9, 2018 News Service

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

FDA Expands Indications for Xeomin

July 6, 2018 News Service

The Food and Drug Administration (FDA) has expanded indications for Xeomin (incobotulinumtoxin A; Merz Neuroscience) to include the treatment of chronic sialorrhea (drooling) in adults.

FDA Safety Alert: Neostigmine Methylsulfate Recalled Due to Mislabeling

July 3, 2018 News Service

Fagron Sterile Services announced a nationwide voluntary recall of 2 lots of neostigmine methylsulfate syringes due to a mislabeling, according a Food and Drug Administration (FDA) safety alert dated June 29, 2018.

FDA News Briefs for Monday, July 2, 2018

July 2, 2018 News Service

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

FDA Approves New Drug Combo for Advanced Melanoma

June 28, 2018 News Service

The Food and Drug Administration (FDA) has approved 2 new oral drugs from Array BioPharma Inc. for the treatment of advanced melanoma in selected patients. Braftovi (encorafenib) and Mektovi (binimetinib) are indicated for combination use to treat unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.

FDA Approves New Antibiotic for Complicated UTIs

June 27, 2018 News Service

On June 26, 2018, the Food and Drug Administration (FDA) approved Zemdri (plazomicin; Achaogen Inc.) to treat adults with complicated urinary tract infections, but the agency declined approval for treating bloodstream infections.