Dynavax And Merck Provide Update On U.S. FDA Clinical Hold On Investigational Vaccine HEPLISAV (Medical News Today)
Dynavax Technologies Corporation (NASDAQ:DVAX) and Merck & Co., Inc. have received communication from the U.S. Food and Drug Administration (FDA) regarding the two companies' response to the agency's request for safety information relating to the clinical hold on the two Investigational New Drug (IND) Applications for HEPLISAVTM, an investigational hepatitis B virus (HBV) vaccine.

FDA lifts Boston Scientific's product approval ban (Lexington Herald-Leader)
Boston Scientific said Wednesday the Food and Drug Administration has lifted some restrictions imposed more than two years due to quality control problems. In 2006 the FDA issued the company a rare "corporate warning letter," which barred the approval of significant new products. Boston Scientific Chief Executive Jim Tobin said the agency has lifted the ban on product approvals. The formal ...

FDA Approves Astellas' Vaprisol(R) (Conivaptan Hydrochloride Injection) Premixed In 5% Dextrose For The Treatment Of ... (Medical News Today)
Astellas Pharma US, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a new premixed formulation of Vaprisol: Vaprisol(R) (conivaptan hydrochloride injection) Premixed in 5% Dextrose.