Search: FDA Approval Headlines from PR Newswire < Go Back ECPA Welcomes EFSA's Scientific Input but sees it as Late and Fears ED Rules will Crush Innovation in Farm Inputs Wed Mar 20 2013, 10:05 ET Quantel Medical Receives FDA Clearance for new Vitra Multispot Laser System Wed Mar 20 2013, 8:00 ET Mylan Launches Generic Version of Xopenex® Inhalation Solution Mon Mar 18 2013, 11:04 ET A Revolutionary Treatment for Burns & Bone Fractures Mon Mar 18 2013, 10:15 ET Anavex comments on FDA plan to expedite approval of new Alzheimer's drugs Mon Mar 18 2013, 9:00 ET Medigus Signed a Distribution Agreement in China Mon Mar 18 2013, 9:00 ET EAS Consulting Group, Experts in Quality Regulatory Services Related to FDA Issues, Announces Upcoming Dietary Supplement Seminars in Salt Lake City Mon Mar 18 2013, 8:35 ET Quidel and Life Technologies Receive FDA Clearance for Clostridium difficile Assay and QuantStudio™ Dx and 7500 Fast Dx Real-Time PCR Instruments Mon Mar 18 2013, 8:00 ET ThromboGenics' JETREA® Granted EU Approval for Vitreomacular Traction (VMT), Including When Associated With Macular Hole of Diameter Less Than or Equal to 400 Microns Fri Mar 15 2013, 9:01 ET Par Pharmaceutical Begins Shipment of Generic Luvox CR® Thu Mar 14 2013, 9:15 ET Neuralstem CEO, Richard Garr, Named To "Top 50 Global Stem Cell Influencers" Thu Mar 14 2013, 9:02 ET FDA Sets 26 August 2013 As New PDUFA Date For MOXDUO® NDA Thu Mar 14 2013, 9:00 ET Medigus Announces $8 Million Private Placement to OrbiMed Wed Mar 13 2013, 13:24 ET Tria Beauty, Inc. and Sephora Announce New U.S. Retail Partnership Wed Mar 13 2013, 7:14 ET SafeCode Drug Technologies Acquires Breakthrough Painless Injection Technology Tue Mar 12 2013, 9:13 ET FDA Grants Chimerix Fast Track Designation for CMX001 for the Prevention of Clinically Significant Cytomegalovirus Infection Tue Mar 12 2013, 7:00 ET invendo medical Announces US Market Entry Following Special 510(k) Clearance By FDA For Computer-Assisted Single-Use Colonoscopy System Mon Mar 11 2013, 6:00 ET Ampio Receives FDA Acceptance of its Patient Outcome for Premature Ejaculation (POPE) Questionnaire, Paving the Way for its US Pivotal Trial on Zertane™ Mon Mar 11 2013, 4:00 ET Food Micro-Fifth Edition: Microbiology Testing in the US Food Industry Fri Mar 8 2013, 12:53 ET Wake Forest Innovations Announces New Commercialization Developments Fri Mar 8 2013, 10:16 ET Actavis Confirms Generic Exelon® Patch Patent Challenge Fri Mar 8 2013, 8:30 ET InspireMD Files Amended Registration Statement for Proposed Public Offering of Common Stock Thu Mar 7 2013, 17:52 ET Galectin Therapeutics Inc. Receives OK from FDA to Proceed with First Human Clinical Trial for Treatment of Fatty Liver Disease with Advanced Fibrosis Tue Mar 5 2013, 9:00 ET Tenaxis Medical®, Inc. Receives FDA Approval for its ArterX® Surgical Sealant Mon Mar 4 2013, 20:31 ET FDA Issues Complete Response Letter for XARELTO® (rivaroxaban) for the Reduction of Cardiovascular Events in Patients with Acute Coronary Syndrome Mon Mar 4 2013, 18:30 ET FDA Clears First Blood Glucose Monitoring System To Automatically Send Results Wirelessly Via Bluetooth® Technology to iOS Devices Mon Mar 4 2013, 14:34 ET Arena Pharmaceuticals Provides Corporate Update and Reviews Fourth Quarter and Full Year 2012 Financial Results Mon Mar 4 2013, 7:00 ET DMH International Announces FDA Approval of TouchPACS Fri Mar 1 2013, 9:20 ET Philips receives FDA clearance to market MicroDose SI mammography system Thu Feb 28 2013, 14:29 ET CSL Behring Receives FDA Approval to Expand the Indication for Corifact® Thu Feb 28 2013, 9:00 ET SynCardia's 50cc Total Artificial Heart Receives Two HUD Designations from the FDA for Destination Therapy and Pediatric Bridge to Transplant Thu Feb 28 2013, 7:55 ET U.S. ARKRAY Announces FDA Clearance of the Fully Automated Integrated Urine Analyzer AUTION HYBRID™ AU-4050 Thu Feb 28 2013, 6:00 ET Cardioviva™ Heart Health Probiotic Achieves FDA Generally Recognized As Safe (GRAS) Status Wed Feb 27 2013, 13:44 ET Recall of Anemia Drug Omontys Rings Alarm Over Biosimilars Wed Feb 27 2013, 11:57 ET Surgical Theater, LLC™ Receives FDA Clearance for Surgery Rehearsal Platform™ Wed Feb 27 2013, 11:09 ET Syneron Beauty Introduces the me smooth At-Home Hair Removal System Wed Feb 27 2013, 6:23 ET Shionogi Receives FDA Approval For Osphena™ (Ospemifene) For The Treatment Of Dyspareunia, A Symptom Of Vulvar And Vaginal Atrophy (VVA), Due To Menopause Tue Feb 26 2013, 15:10 ET Tandem Diabetes Care Announces FDA Clearance of t:connect Diabetes Management Application for Use with t:slim Insulin Pump Tue Feb 26 2013, 9:00 ET Bayer's Stivarga® (regorafenib) Tablets Approved by U.S. FDA for Treatment of Patients with Locally Advanced, Unresectable or Metastatic GIST Mon Feb 25 2013, 16:05 ET Actavis' Generic Suboxone® Receives FDA Approval Mon Feb 25 2013, 7:30 ET Lupin Receives FDA Approval for New Drug Application for SUPRAX® Oral Suspension, 500 mg/5mL Fri Feb 22 2013, 8:20 ET Lupin Receives FDA Approval for New Drug Application for SUPRAX® Oral Suspension, 500 mg/5mL Fri Feb 22 2013, 8:20 ET CSL Behring Announces New Vial Size of Privigen® for Treatment of Primary Immunodeficiency and Chronic Immune Thrombocytopenic Purpura Thu Feb 21 2013, 9:00 ET FDA Publicly Challenged to Support Unsubstantiated Claims Regarding Electronic Cigarettes Wed Feb 20 2013, 8:00 ET UCB Announces Regulatory Filings for Cimzia® (Certolizumab Pegol) to Treat Psoriatic Arthritis and Axial Spondyloarthritis Wed Feb 20 2013, 7:00 ET Perfect Your Physique Tue Feb 19 2013, 9:30 ET InSightec's ExAblate Neuro Receives the Go-ahead from FDA to Begin its Pivotal Phase III trial for Essential Tremor Tue Feb 19 2013, 9:21 ET Perrigo Confirms First to File Patent Challenge for Generic Version of Testosterone Gel 1.62% Tue Feb 19 2013, 9:19 ET Epiduo® Gel Becomes First Topical Prescription Acne Treatment Available For Children As Young As 9 Years Old Tue Feb 19 2013, 9:00 ET ElectroCore® Receives Australian and Colombian Regulatory Approval for GammaCore® Vagal Nerve Stimulation Therapy Tue Feb 19 2013, 9:00 ET < Prev Next >