Search: FDA Approval Headlines from PR Newswire < Go Back FDA Advisory Committee recommends approval of BREO™ ELLIPTA™ for the treatment of COPD Wed Apr 17 2013, 17:18 ET Novel Cancer Immunotherapy set to enter Clinical Trials Tue Apr 16 2013, 19:00 ET VIVUS Announces FDA Approval of Qsymia REMS Modification Allowing Access Through Certified Retail Pharmacies Tue Apr 16 2013, 14:30 ET InspireMD Closes $25 Million Underwritten Public Offering Tue Apr 16 2013, 11:20 ET Pittsburgh-Based Rinovum® Women's Health Readies for Market Tue Apr 16 2013, 10:18 ET Oramed Pharmaceuticals Appoints New Chief Operating Officer and VP of Business Development Tue Apr 16 2013, 9:15 ET FDA Approves FibroScan® for Non-invasive Liver Diagnosis Tue Apr 16 2013, 9:00 ET YES Pharma Announces $2.5 Million Investment in Stereokem for 33% Ownership Tue Apr 16 2013, 8:00 ET Tria Beauty, Inc. and Ulta Announce New Retail Partnership Tue Apr 16 2013, 7:43 ET ORTHOWORLD(R) Announces FDA Official to Serve as Panelist at Orthopaedic Manufacturing & Technology Exposition and Conference (OMTEC(R)) Fri Apr 12 2013, 9:52 ET Boston Scientific Launches Precision Spectra™ Spinal Cord Stimulator System In The United States Fri Apr 12 2013, 9:03 ET Hawaii Vision Clinic Introduces ChromaGen Life-Changing Lens Technology Thu Apr 11 2013, 13:00 ET Elekta Receives U.S. FDA 510(k) Clearance Following Launch of New Versa HD Radiation Therapy System for Cancer Treatment Thu Apr 11 2013, 9:13 ET MAQUET Cardiovascular Receives FDA 510(k) Clearance And CE Mark Approval For AIR-BAND™ Radial Compression Device Thu Apr 11 2013, 8:00 ET BD Announces FDA 510(k) Clearance and Commercial Launch of BD UltraSafe PLUS™ Passive Needle Guard Thu Apr 11 2013, 8:00 ET Oramed Submits New IND Application for Oral Insulin Trial in the US Thu Apr 11 2013, 3:11 ET InspireMD Announces Pricing of Underwritten Public Offering of Common Stock and Listing on NYSE MKT Wed Apr 10 2013, 22:00 ET Olympus Introduces the World's Only Articulating HD 3D Laparoscopic Surgical Video System Tue Apr 9 2013, 8:30 ET New Molecular Assay Provides Healthcare Facilities with a Simple, Efficient Way to Detect Dangerous Superbug Tue Apr 9 2013, 8:00 ET FDA Approves Duchesnay USA's Diclegis® for Treatment of Nausea and Vomiting of Pregnancy (NVP) Mon Apr 8 2013, 20:51 ET Bausch + Lomb Receives FDA Approval for PROLENSA™ (bromfenac ophthalmic solution) 0.07% Mon Apr 8 2013, 7:30 ET Ibrutinib Receives Third Oncology Breakthrough Therapy Designation from U.S. Food and Drug Administration Mon Apr 8 2013, 6:30 ET Emergency Contraception to Be Available on Store Shelves Fri Apr 5 2013, 9:54 ET Hadasit Bio-Holdings Flagship Portfolio Company Enlivex Awarded Orphan Drug Status for ApoCell Treatment by the FDA Thu Apr 4 2013, 9:11 ET CryoLife Receives FDA Clearance For Next Generation HeRO Device Thu Apr 4 2013, 8:34 ET Mylan Launches First Generic Version of Zovirax® Ointment Wed Apr 3 2013, 15:01 ET FDA Approves Tris Pharma's New Drug Application for Karbinal™ ER (carbinoxamine maleate) Extended-release Oral Suspension Wed Apr 3 2013, 7:30 ET Statement from GlaxoSmithKline Consumer Healthcare on FDA Report Regarding FDA's Changes to the Labeling of Over-the-Counter Nicotine Medications Mon Apr 1 2013, 14:24 ET U.S. FDA Approves INVOKANA™ (Canagliflozin) for the Treatment of Adults with Type 2 Diabetes Fri Mar 29 2013, 16:37 ET Third FDA Clearance for Revolutionary Simbionix Product Fri Mar 29 2013, 10:00 ET Third FDA Clearance for Revolutionary Simbionix Product Fri Mar 29 2013, 10:00 ET New Abbott Test Can Help Doctors Detect the Presence of Two Important Health Issues Thu Mar 28 2013, 8:00 ET BD Enters Pharmaceutical Industry with New Line of Generic Prefilled Injectable Products Wed Mar 27 2013, 8:00 ET FDA Approves ACIPHEX® Sprinkle™ (Rabeprazole Sodium) For Use in Children Ages 1 to 11 Tue Mar 26 2013, 20:51 ET MedNet Solutions To Participate In Multiple Clinical Research Conferences In April 2013 Tue Mar 26 2013, 15:03 ET Breckenridge announces agreement with Aptalis Pharmatech to market Propranolol Hydrochloride Extended-Release Capsules Tue Mar 26 2013, 12:33 ET Boehringer Ingelheim and Eli Lilly and Company submit new drug application to FDA for empagliflozin, an investigational type 2 diabetes treatment Mon Mar 25 2013, 8:00 ET Vanda Reports Successful Completion Of Pre-NDA Meeting With FDA On Tasimelteon For The Treatment Of Non-24-Hour Disorder In The Totally Blind Mon Mar 25 2013, 6:55 ET United Therapeutics Announces Receipt Of Second Complete Response Letter For Oral Treprostinil NDA Mon Mar 25 2013, 5:00 ET FDA approves Novartis TOBI® Podhaler™ for certain cystic fibrosis patients, the first and only dry powder inhaled antibacterial in US Fri Mar 22 2013, 20:54 ET FDA Approves Dotarem® (gadoterate meglumine), first macrocyclic and ionic gadolinium-based contrast agent in USA Thu Mar 21 2013, 10:18 ET SafeCode Drug Technologies Initiating Activities to Commercialize its Recent Newly Acquired Technology of the Pain-Free Injection Thu Mar 21 2013, 9:00 ET Piramal Imaging Announces the Acceptance for Review of [18F] florbetaben by the FDA and EMA for the Visual Detection of beta-amyloid in Alzheimer's Disease Thu Mar 21 2013, 7:04 ET FDA Advisory Committee Votes Favorably on Abbott's Minimally Invasive MitraClip® Device for Patients with Significant Mitral Regurgitation Who Are Too High Risk for Surgery Wed Mar 20 2013, 19:44 ET Pew Commends Senators Gillibrand and Feinstein for Working to Shine Light on Antibiotics Practices Wed Mar 20 2013, 15:57 ET ENCO Pharmaceutical Development Announces Another Successful FDA Inspection - Its 2nd This Year Wed Mar 20 2013, 10:21 ET 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 < Prev Next >