News Service

late-breaking news in healthcare

FDA Expands Approval for Cabometyx

January 17, 2019 News Service

The Food and Drug Administration (FDA) has granted expanded approval for Cabometyx (cabozantinib; Exelixis Inc.) for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

USPSTF Releases New Draft Recommendations on Breast Cancer Risk Reduction

January 16, 2019 News Service

The U.S. Preventive Services Task Force (USPSTF) has released a draft recommendation on Breast Cancer: Medication Use to Reduce Risk.

FDA Approves Amplatzer Piccolo Occluder for PDA Closure in Infants

January 15, 2019 News Service

The Food and Drug Administration (FDA) has granted a supplemental premarket approval (PMA) for the Amplatzer Piccolo Occluder, a medical device implant for the nonsurgical closure of patent ductus arteriosus (PDA).

CDC Reports Significant Increase in Drug Overdose Deaths Among Women

January 14, 2019 News Service

Drug overdose death rates in women in the U.S. have increased by 260 percent since 1999, according to the Centers for Disease Control and Prevention (CDC).

FDA Safety Alerts

January 9, 2019 News Service

These Food and Drug Administration (FDA) safety alerts were posted this week.

FDA Grants De Novo Clearance for Concussion Diagnostic Aid

January 8, 2019 News Service

The Food and Drug Administration (FDA) has granted a de novo marketing authorization for the EyeBOX (Oculogica Inc.), a device that measures eye movements to assess brain function.

FDA News Briefs for Monday, January 7, 2019

January 7, 2019 News Service

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

Partial Government Shutdown Impacts FDA Operations

January 2, 2019 News Service

The Food and Drug Administration (FDA) has announced that beginning on December 22, 2018, the agency is temporarily unable to accept any regulatory submissions for fiscal year 2019 that require a fee payment due to unresolved disputes over the U.S. federal budget.

FDA News Briefs for Thursday, December 27, 2018

December 27, 2018 News Service

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

FDA News Briefs for Friday, December 21, 2018

December 21, 2018 News Service

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