FDA Approvals - FDA Allows Phase 2 Study For Sound Pharmaceuticals' Novel Drug
FDA Allows Phase 2 Study For Sound Pharmaceuticals' Novel Drug To Prevent Chemotherapy Induced Hearing Loss (Medical News Today)
Sound Pharmaceuticals (SPI) has received FDA notification that it may proceed with its Phase II study to prevent chemotherapy induced hearing loss.
Multaq(R) (dronedarone) Granted FDA Priority Review For Patients With Atrial Fibrillation (Medical News Today)
Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced that U.S. Food and Drug Administration (FDA) has assigned priority review status for its New Drug Application (NDA) for Multaq(R) (dronedarone). The priority review period begins on July 31, 2008.
Meridian Co., Ltd. Issues Statement About FDA & Financials (Marketwire via Yahoo! Finance)
Meridian Co., Ltd., a company engaged in the research, development, manufacturing, and sales of advanced medical devices, has issued the following statement regarding the continuing delay in FDA 510(k) clearance for its Lapex-2000 LipoLaser and other matters: