News Service

late-breaking news in healthcare

Recall of Cantrell Drug Company Products Due to Sterility Concerns

July 27, 2017 News Service

Cantrell Drug Company is voluntarily recalling all lots of unexpired sterile drug products because the company cannot assure that these products are sterile.

Yervoy Now Indicated to Treat Pediatric Unresectable or Metastatic Melanoma

July 26, 2017 News Service

The Food and Drug Administration (FDA) has expanded indications for Yervoy (ipilimumab, Bristol-Myers Squibb) to include pediatric patients with unresectable or metastatic melanoma. Yervoy is an intravenous immunotherapy initially approved by the FDA in 2011 to treat unresectable or metastatic melanoma in adults.  

FDA Announces Launch of Expanded Access Navigator

July 25, 2017 News Service

The Food and Drug Administration (FDA) has announced the launch of the Expanded Access Navigator, a new online tool for patients with serious or immediately life-threatening diseases or conditions who seek access to potentially life-saving investigational drugs.

FDA News Briefs for Monday, July 24, 2017

July 24, 2017 News Service

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

CDC Releases New Statistics on Diabetes and Prediabetes

July 21, 2017 News Service

More than 100 million adults in the United States are living with diabetes or prediabetes as of 2015, according to a recent report from the Centers for Disease Control and Prevention (CDC).  

First DAA Combo Pill for HCV Approved as Salvage Therapy

July 20, 2017 News Service

The Food and Drug Administration (FDA) has approved a pan-genotypic triple direct-acting antiviral (DAA) combination pill for the treatment of hepatitis C virus infection in patients previously treated with the DAA drug sofosbuvir or other NS5A inhibitors.  

FDA Approves First Extended Adjuvant Therapy for HER2-Positive Breast Cancer

July 19, 2017 News Service

On July 17, 2017, the Food and Drug Administration (FDA) approved Nerlynx (neratinib; Puma Biotechnology) for extended adjuvant treatment in patients with early-stage HER2-positve breast cancer who have first completed standard adjuvant treatment with Herceptin (trastuzumab; Genentech/Roche). Nerlynx is the first FDA-approved drug indicated for extended adjuvant therapy in this patient population.

FDA Advisory Panel Unanimously Endorses Avastin and Herceptin Biosimilars

July 18, 2017 News Service

Last Thursday, a Food and Drug Administration (FDA) advisory committee unanimously recommended approval for biosimilar versions of 2 top-selling cancer therapies: Avastin (bevacizumab; Genentech and Roche) and Herceptin (trastuzumab; Genentech).

FDA News Briefs for Monday, July 17, 2017

July 17, 2017 News Service

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

FDA Advisory Panel Endorses CAR T-Cell Therapy

July 14, 2017 News Service

A Food and Drug Administration (FDA) advisory committee has unanimously endorsed the CAR T-cell therapy tisagenlecleucel (CTL019, Novartis) for pediatric and young-adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia. The FDA is not required to follow the recommendations of its advisory committees.