Post Tagged with: "FDA"

Gilead Sciences Says FDA Accepts New Drug Applications for Cobicistat and Elvitegravir for HIV Therapy

April 21, 2014 at 8:20 pm

Gilead Sciences (GILD) says the FDA accepted the company’s refiling of two New Drug Applications (NDA) for cobicistat, a pharmacoenhancing or “boosting” agent that increases blood levels of the protease inhibitors atazanavir and darunavir to enable once-daily dosing of these medicines in HIV therapy, and elvitegravir, an integrase inhibitor forRead More

GE Healthcare Announces FDA Clearance Of New CT Scanner, GE Shares Edge Up

April 17, 2014 at 3:24 pm

General Electric’s (GE) GE Healthcare unit announced FDA clearance of its new CT scanner that is designed to provide superior imagery in cardiology, oncology and neurology applications. The company said the Revolution CT will enable diagnosis via the convergence of coverage, spatial resolution and temporal resolutions in a single CTRead More

Syneron Medical Climbs 5% on FDA Clearance to Market UltraShape System for Fat Cell Destruction

April 17, 2014 at 3:16 pm

Shares in Syneron Medical (ELOS), an aesthetic medical device company, are higher after the company said Monday that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market the UltraShape System to reduce abdominal fat. Shares are now up 4.89% at $11.80, with a 52-week range ofRead More

BioMarin Pharmaceutical Up 2% on FDA Market Exclusivity Extension for Rare Disease Therapy KUVAN

April 17, 2014 at 3:14 pm

BioMarin Pharmaceutical (BMRN) shares are higher after the company said Monday that the U.S. Food and Drug Administration (FDA) granted KUVAN powder a six-month pediatric exclusivity extension. Shares are up 1.26% at $57.97, with a 52-week range of $53.53 – $84.25. The company, which develops and commercializes therapies for rareRead More