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May 24, 2012, 08:59 ET
SRS Endoscopic System Receives FDA Clearance for Treatment of Gastroesophageal Reflux Disease (GERD)
The SRS system by Medigus, offers endoluminal treatment for one of the most common chronic conditions Medigus Ltd. (TASE: MDGS) announced that... -
May 24, 2012, 07:00 ET
Cepheid Receives FDA Clearance for GeneXpert Infinity-80 System for Initial Use with Xpert Flu Assay
Cepheid (NASDAQ: CPHD) today announced that the U.S. Food & Drug Administration (FDA) has cleared its GeneXpert® Infinity-80 System, a... -
May 23, 2012, 16:43 ET
FDA Advisory Committee Recommends Against Approval of Oral Anticoagulant XARELTO® to Reduce the Risk of Secondary Cardiovascular Events in Patients with Acute Coronary Syndrome
Janssen Research & Development, LLC (Janssen) announced today that the U.S. Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs... -
May 23, 2012, 12:33 ET
New Drug Application for Regorafenib for the Treatment of Metastatic Colorectal Cancer Submitted by Bayer
Onyx Pharmaceuticals, Inc. today announced that Bayer HealthCare has submitted a New Drug Application (NDA) to the U.S. Food and Drug... -
May 23, 2012, 11:42 ET
Mylan Launches Generic Version of Viramune® Tablets
Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and... -
May 23, 2012, 06:01 ET
TriReme Medical, Inc. Receives FDA Approval for Glider™ PTCA Catheter
TriReme Medical, Inc. (TMI) today announced approval by the U.S. Food and Drug Administration (FDA) of the Glider™ PTCA Catheter, indicated... -
May 22, 2012, 16:38 ET
Perrigo Receives FDA Approval for Butoconazole Nitrate 2% Vaginal Cream
Perrigo Company (Nasdaq: PRGO;TASE) today announced that it has received final approval from the U.S. Food and Drug Administration for its... -
May 22, 2012, 09:07 ET
FDA Approves Levemir® for Expanded Use in Children Two to Five Years of Age with Type 1 Diabetes
Novo Nordisk, a world leader in diabetes care, announced today that the U.S. Food and Drug Administration (FDA) has approved Levemir®... -
May 21, 2012, 14:18 ET
Nonin Medical, Inc. Announces FDA 510(k) Clearance Expanded Labeling for Onyx® Vantage 9590 Professional Fingertip Pulse Oximeter at ATS Annual Meeting
Nonin Medical, Inc., the inventor of finger pulse oximetry and a leader in noninvasive medical monitoring, today announced commercial release... -
May 21, 2012, 10:26 ET
Study Results of Novocure's NovoTTF™ Pivotal Phase 3 Trial Published in European Journal of Cancer
Results of the first randomized controlled trial to compare a novel cancer treatment modality delivering Tumor Treating Fields... -
May 21, 2012, 09:30 ET
Bureaucrats Aim To Put Nanotech 'Under The Electron Microscope,' Says Veteran Environmental Attorney
Federal regulators want to launch a series of in-depth studies into the risks of nanotechnology and nano-scale materials. While some in the... -
May 21, 2012, 05:24 ET
Oramed Pharmaceuticals to Present at the 11th National Life Science & Technology Week ILSI-BIOMED Conference; Tel Aviv, Israel, 2012
Oramed Pharmaceuticals Inc. (OTCBB: ORMP.OB), a developer of oral delivery systems, announced today that it was chosen to present at the... -
May 18, 2012, 13:32 ET
Perrigo Announces FDA Final Approval and Launch of Store Brand OTC Lansoprazole 15mg Capsules
Perrigo Company (Nasdaq: PRGO;TASE) today announced that it has received final approval from the U.S. Food and Drug Administration for its... -
May 18, 2012, 12:11 ET
Digestive Care, Inc. Announces FDA Approval of PERTZYE™ (pancrelipase) Delayed-Release Capsules
Digestive Care, Inc. (DCI), announced that the company has received U.S. Food and Drug Administration (FDA) approval of its New Drug... -
May 18, 2012, 09:00 ET
Actavis Launches First Generic Equivalent of Requip® XL (Ropinirole Extended-Release Tablets)
Actavis Group, an international generic pharmaceuticals company, today announced that it received US FDA approval of Ropinirole... -
May 17, 2012, 17:14 ET
Boston Scientific Announces FDA Approval and U.S. Launch of EPIC™ Vascular Stent
Boston Scientific Corporation (NYSE: BSX) announces U.S. Food and Drug Administration approval and market launch of the Epic™ Vascular... -
May 17, 2012, 13:41 ET
Mylan Launches Generic Version of Plavix® Tablets
Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and... -
May 17, 2012, 08:00 ET
Ambit Biosciences and Teva Announce Clearance of an Investigational New Drug (IND) Application for CEP-32496, A Novel BRAF(V600E) Inhibitor
Ambit Biosciences and Teva Pharmaceutical Industries Limited (NASDAQ: TEVA) ("Teva") today announced the clearance of an Investigational... -
May 16, 2012, 14:30 ET
Immune Deficiency Foundation Urges FDA To Exempt Immunoglobulin From Biosimilars Pathway
In an effort to voice concern on biosimilars pathways for patients with primary immunodeficiency diseases (PIDD), the Immune Deficiency... -
May 16, 2012, 12:58 ET
PneumRx, Inc. recibe la aprobación de la FDA para comenzar el ensayo clínico pivote del sistema RePneu LVRC
- PneumRx, Inc. recibe la aprobación de la FDA para comenzar el ensayo clínico pivote del sistema de espiral de reducción de volumen...
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