Latest FDA Stories

- FDA IDE approval supports expansion of SMART Clinical Trial to 20 Clinical Sites REDWOOD CITY, Calif., April 10, 2013 /PRNewswire/ -- Relievant Medsystems, Inc., a privately held medical device company pioneering the therapeutic use of basivertebral nerve ablation for the treatment of chronic axial low back pain, announced today that it has completed a pre-planned interim review of safety results of the company's SMART Clinical Trial evaluating its Intracept therapy for chronic...

BLAINVILLE, QC, April 9, 2013 /CNW Telbec/ - Following the US approval of its morning sickness medication Diclegis by the US Food and Drug Administration (FDA), the Canadian pharmaceutical company Duchesnay Inc. is proud to announce that this approval sets the obstetric medicine specialty company for international expansion. Diclegis has been available in Canada under the trade name Diclectin® for more than 30 years as the only prescription drug specifically indicated and...

BD MAX(TM) Cdiff Assay Receives FDA Clearance BALTIMORE, April 9, 2013 /PRNewswire/ -- BD Diagnostics, a segment of BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced it received FDA clearance to market the BD MAX(TM) Cdiff Assay in the United States. The assay is performed on the fully-automated BD MAX(TM) System and is designed to rapidly and accurately detect the toxin B gene (tcdB), which has been shown to be essential to...

In the news release, FDA Approves Duchesnay USA's Diclegis® for Treatment of Nausea and Vomiting of Pregnancy (NVP), issued 08-Apr-2013 by Duchesnay USA over PR Newswire, we are advised by the company that Laney Cohen's phone number should read "(212) 508-9643" rather than "(215) 508-9643" as originally issued inadvertently. The complete, corrected release follows: FDA Approves Duchesnay USA's Diclegis® for Treatment of Nausea and Vomiting of Pregnancy (NVP) Diclegis becomes only...

Diclegis becomes only FDA-approved treatment for "morning sickness" in decades ROSEMONT, Pa., April 8, 2013 /PRNewswire/ -- Duchesnay USA today announced that the Food and Drug Administration (FDA) has granted approval for Diclegis(®) (doxylamine succinate 10mg, pyridoxine hydrochloride 10mg) delayed-release tablets for the treatment of nausea and vomiting of pregnancy (NVP) in women who do not respond to conservative management.(i) It is the only FDA-approved treatment for NVP,...

SAN FRANCISCO, April 8, 2013 /PRNewswire/ -- The site is a comprehensive resource for vaginal mesh lawsuit compensation, news and a guide for women with vaginal mesh side effects. Watch a series of video interviews with Dr. Vigna interviewing Dr. Michael Hibner, a renowned expert in the field of Urogynecology. Five years after the FDA first warned of risks associated with mesh implant surgery there has been an astronomical increase in reported injury cases. U.S. - More and more...

WAYNE, N.J., April 8, 2013 /PRNewswire/ -- Bayer HealthCare announced today that the New Drug Application (NDA) for its oral investigational compound riociguat has been accepted for filing and granted priority review by the U.S. Food and Drug Administration (FDA) for the treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or with persistent or recurrent CTEPH after pulmonary endarterectomy (PEA) and pulmonary arterial hypertension (PAH). Both CTEPH and PAH are...

Dr. Jason Cataldo now treats patients with gum disease by using the most up-to-date treatments available. The Laser Assisted New Attachment Procedure is a minimally invasive laser gum surgery that gently removes bacteria and diseased gum tissue, and recovery times are generally short with most patients returning to work by the next day. Durham, NC (PRWEB) April 05, 2013 Dr. Jason Cataldo now utilizes the FDA cleared PerioLase MVP-7 laser to perform laser gum surgery on patients suffering...

Two Steps Closer to a Viable Treatment for Spinal Cord Injuries GREENWICH, Conn., April 5, 2013 /PRNewswire/ -- Spencer Trask, a venture capital firm focused on developing big ideas into world-changing companies, congratulates InVivo Therapeutics (NVIV), for its recent approvals from the U.S. Food and Drug Administration (FDA). On the heels of FDA approval for Humanitarian Use Device (HUD) designation (an important benchmark and speed-to-market catalyst), InVivo has received yet...

Major milestone achieved as orphan status grants Enlivex seven years of exclusivity for treatment based on immune tolerance for GVHD JERUSALEM, April 4, 2013 /PRNewswire/ -- Hadasit Bio-Holdings Ltd. (TASE: HDST, OTC: HADSY), a publicly traded portfolio of biotech companies, all based on intellectual property developed and owned by Hadassah University Hospital, Israel's foremost medical research center, announced today that one of its flagship portfolio companies, Enlivex...