FDA Approval Headlines from PR Newswire

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Shimadzu Sonialvision G4 universal R/F system receives FDA clearance
FDA Approves Roche's HPV Test for First-Line Primary Screening for Cervical Cancer
Oramed Pharmaceuticals Presents Data from Phase IIa Trial with ORMD-0801 in Type 2 Diabetes at the 2014 Diabetes Summit
Lorillard Responds to Proposed FDA Deeming Regulations for Electronic Cigarettes
SYLVANT™ (siltuximab) Receives FDA Approval to Treat Multicentric Castleman's Disease (MCD)
Migraine Prevention Device CEFALY® Now Available for US Purchase and Delivery
FDA Grants Orphan Drug Designation for Bayer's Investigational Ciprofloxacin DPI (Dry Powder for Inhalation) for Treatment of Non-Cystic Fibrosis Bronchiectasis
Lilly's CYRAMZA™ (ramucirumab) Becomes First FDA-Approved Treatment for Advanced Gastric Cancer After Prior Chemotherapy
GSK and Genmab receive FDA approval for Arzerra® (ofatumumab) as first-line treatment in combination with chlorambucil for patients with Chronic Lymphocytic Leukaemia (CLL) for whom fludarabine-based therapy is considered inappropriate
Volasertib, Boehringer Ingelheim's Investigational Oncology Compound, is Granted Orphan Drug Designation for Acute Myeloid Leukemia in the U.S. and EU
Breathe Technologies, Inc. Announces FDA Clearance For NIOV System For Use With Compressed Gas
Retail Sales Poised For Growth With Launch Of UniStrip Generic Blood Glucose Test Strips
Syneron to Host Conference Call and Webcast to Discuss UltraShape FDA Clearance
Ending Neostigmine Methylsulfate Injection Shortages With BLOXIVERZ®, The Only FDA-Approved Neostigmine Methylsulfate Injection
Prodigy Diabetes Care Moves Forward After FDA Concludes Regulatory Action
Boston Scientific Announces FDA Approval Of Innovative New Defibrillators And Heart Failure Devices
Zogenix Announces Ruling Preventing the Implementation of Massachusetts Governor's Order that Prevented Access to Zohydro™ ER
GSK receives US approval for once-weekly type 2 diabetes treatment, Tanzeum™ (albiglutide) English
Medac Pharma, Inc. Secures FDA Approval of Trade Name Rasuvo™ for Lead Methotrexate Subcutaneous Injectable Product
Mylan Launches Generic Lunesta® Tablets
Collagen Matrix, Inc. Receives FDA 510(k) Clearance of a Flexible Collagen Nerve Conduit for Reduction of Painful Neuroma Formation
Beyond the Hype of Global Next-Generation Sequencing Informatics: Inflated Expectations in an Emerging Market
Fast, High Definition, Low Dose: GE Healthcare Announces FDA Clearance of Revolution CT
Abbott Announces FDA Clearance for a New Test to Help Physicians Quickly and Accurately Diagnose Diabetes
Syneron Receives US FDA Clearance to Market the UltraShape System for Fat Cell Destruction
QIAGEN Adds Promising New Biomarker to Pipeline of Personalized Healthcare Assays to Improve Diagnosis of Blood Disorders
FDA Approves Lipiodol® (Ethiodized Oil) Injection for Imaging of Tumors in Adults with Known Hepatocellular Carcinoma (HCC)
Oramed Granted Patent in Hong Kong for Oral Administration of Insulin
FDA Approval Process for Medical Devices - Updated Programme Includes all the Current FDA Guidelines (Seminar, London)
Parents Ask FDA to Approve Duchenne Muscular Dystrophy Drug; The Race to Yes Seeks Decisive Eteplirsen Decision Within 30 Days
Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5 percent and 10 percent Readily Available
Updated with Multimedia Content: FDA Approves Pradaxa® (dabigatran etexilate mesylate) for Treatment and Reduction in the Risk of Recurrence of Deep Venous Thrombosis and Pulmonary Embolism
Waismann Method: Prescription painkiller/heroin overdose antidote approved by FDA
GE Healthcare Receives FDA Clearance For Q.Clear Technology
Biosafe Achieves Full Registration in China
Boston Scientific Introduces the Expect™ Slimline (SL) Needle for Use During Endoscopic Ultrasound Fine Needle Aspiration Procedures
USPTO Grants a New Inhaler Patent to Hovione
Par Pharmaceutical Begins Shipment of Potassium Chloride Extended-Release Capsules
FDA Approves Pradaxa® (dabigatran etexilate mesylate) for Treatment and Reduction in the Risk of Recurrence of Deep Venous Thrombosis and Pulmonary Embolism
Nexcyon Achieves European Regulatory Decision Spanish
Diplomat to distribute Otezla® (apremilast), newly approved medication for psoriatic arthritis
Via Surgical Ltd. Receives FDA Clearance to Commercialize FasTouch(TM), the First Suture-Like Mesh Fixation System for Hernia Repair
Syneron's Innovative Products Featured at 34th ASLMS Annual Conference
FDA, HHS Reaffirm Support for Chronic Pain Patients Amid Zohydro ER Debate
Escalon® Medical Corp. Receives FDA 510(k) Clearance for the Sonomed Escalon VuPad™
U.S. Food and Drug Administration Approves Kaleo's EVZIO™ for the Emergency Treatment of Opioid Overdose
U.S. Food and Drug Administration Approves Kaleo's EVZIO™ for the Emergency Treatment of Opioid Overdose
Investigational New Drug Application Cleared by FDA for OMS721 in Thrombotic Microangiopathies
Syneron Sublative Technology Earns CE Mark for Stretch Mark and Acne Scar Treatment
Ablative Solutions Receives FDA Clearance for the Peregrine System™ Infusion Catheter

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