Food and Drug Administration (FDA)

The U.S. Food and Drug Administration (FDA)’s Circulatory System Devices Panel is in the middle of two days of presentations and meetings regarding mortality rates associated with the use of paclitaxel-coated balloons (DCBs) and paclitaxel-eluting stents (DESs). The discussions are noting missing data and conflicting analysis.

Bavarian Nordic A/S announced the initiation of a pivotal Phase 3 trial of the freeze-dried formulation of MVA-BN® smallpox vaccine in 1,110 healthy, vaccinia-naïve subjects.

Lawsuits against the FDA are fairly common. However, winning the lawsuit will be a tough road for Catalyst, as other pharma companies that challenged the regulatory agency learned.

The approval marks the first glucagon-like peptide-1 (GLP-1) receptor agonist approved for children and adolescents with type 2 diabetes.

KB105 is a new gene therapy candidate engineered with a Transglutaminase-1 (TGM1) gene construct to treat TGM1 deficient autosomal recessive congenital ichthyosis

June is turning out to be a busy month for approvals for the U.S. Food and Drug Administration. The agency has a slate of PDUFA dates this week, including two for Merck alone. Here’s a look.

The stool sample used in the experimental procedure was not properly tested, the FDA said.

Clinical Ink is pleased to announce that Jonathan Andrus, chief business officer at Clinical Ink, has been invited to be a panelist in a public meeting hosted by the Duke-Margolis Center for Health Policy on July 17, 2019, in Washington, D.C. The workshop, convened under a cooperative agreement with the FDA, will discuss opportunities to improve the implementation of risk-based monitoring (RBM) in clinical investigations.

Complaint Cites Multiple Violations of Food, Drug, and Cosmetic Act