FDA Approvals - FDA Panel Says Pfizer's New Osteoporosis Drug Has Benefits But
FDA Panel Says Pfizer's New Osteoporosis Drug Has Benefits But Use Should Be Restricted (Medical News Today)
A panel that advises the US Food and Drug Administration (FDA) on new drug approvals said the benefits of Pfizer's bone drug Fablyn for treating postmenopausal women with osteoporosis outweighed the risks but that use should be restricted to patients at high risk of fracture or who have tried other treatments without success.
MiCardia Corporation Receives US FDA Market Clearance For Dynaplasty Annuloplasty Devices (Medical News Today)
MiCardia Corporation announced that the U.S. Food and Drug Administration ("FDA") has granted 510(k) marketing clearance for its Dynaplasty Annuloplasty Band DR and Annuloplasty Ring DR. These are the first of MiCardia's innovative Dynaplasty Technology products to receive clearance.
Cardica Receives 510(k) Clearance To Market PAS-Port(R) Proximal Anastomosis System For Use In Cardiac Bypass Surgery (Medical News Today)
Cardica, Inc. (Nasdaq: CRDC) announced that the U.S. Food and Drug Administration (FDA) has granted the company 510(k) clearance to market its PAS-Port(R) Proximal Anastomosis System for use in cardiac bypass surgery.