FDA Issues Complete Response Letter For Ceftobiprole For Treatment Of Complicated Skin Infections (Medical News Today)
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ceftobiprole for the treatment of complicated skin and skin structure infections, including diabetic foot infections.

PLC Systems Receives Full FDA Approval For Pivotal Study Of RenalGuard(TM) In The U.S. (Medical News Today)
PLC Systems Inc. (OTC Bulletin Board: PLCSF) announced that it has received full approval from the U.S. Food and Drug Administration (FDA) for its U.S. pivotal trial to study the effectiveness of the Company's RenalGuard System(TM) and associated therapy in the prevention of Contrast-Induced Nephropathy (CIN).