FDA Approvals - Pharmasset Voluntarily Halts Clinical Studies With Clevudine In Hepatitis B
Pharmasset Voluntarily Halts Clinical Studies With Clevudine In Hepatitis B Infected Patients (Medical News Today)
Pharmasset, Inc. (Nasdaq: VRUS) announced that after a discussion with its independent Data Safety Monitoring Board (DSMB) and the FDA, the company has decided to voluntarily terminate its Phase III QUASH studies of clevudine for the treatment of chronic hepatitis B (HBV) infection.
Thoratec Announces Filing Of PMA Seeking Destination Therapy Approval For HeartMate II(R) (Medical News Today)
Thoratec Corporation (Nasdaq: THOR), a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, said that it has filed a PMA (Pre-Market Approval) supplement with the FDA seeking to add the intended use of Destination Therapy (DT) for the HeartMate II LVAS (left ventricular assist system).
BIOLASE Announces FDA 510(K) Clearance Of Its Ezlase(TM) Diode Laser For Pain Therapy & Relief (Medical News Today)
BIOLASE Technology, Inc. (NASDAQ: BLTI), the world's leading dental laser company, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its ezlase(TM) diode laser system for therapeutic applications including temporary pain relief. The cleared indications are broad to cover medical and dental.