FDA Approvals - ABIOMED Receives FDA Approval to Commence IMPELLA 2.5 U.S. Trial;
ABIOMED Receives FDA Approval to Commence IMPELLA 2.5 U.S. Trial; Indication for Use is Support During High-Risk (FinanzNachrichten)
ABIOMED, Inc. (NASDAQ: ABMD) today announced that the U.S. Food and Drug Administration (FDA) granted approval for the Company to commence its pilot clinical trial immediately in the United States for the IMPELLA(R) 2.5 minimally invasive ventricular assist device (VAD). The approval is conditioned upon the Company's submission of additional information to the FDA over the next 45 days.
Teva to launch generic Zocor in June (Globes Online)
Leader: Revenue from the product will be $250 million in six months, and Teva will continue to fight the FDA over exclusivity.