Search: FDA Approval Headlines from PR Newswire < Go Back RegeneCure Starts Clinical Study Using Polymeric Bone Stimulating Membrane for Dental Implants Tue Jun 18 2013, 9:00 ET Mentor Receives FDA Approval For MENTOR® MemoryShape™ Breast Implants Fri Jun 14 2013, 12:54 ET Cempra Provides Guidance on the Clinical Program Required for Regulatory Approval for Solithromycin for Community-Acquired Bacterial Pneumonia (CABP) Thu Jun 13 2013, 16:02 ET FDA Approves Amgen's XGEVA® (denosumab) For The Treatment Of Giant Cell Tumor Of Bone Thu Jun 13 2013, 15:11 ET Orthopaedic Device Manufacturers Have No Choice: Unique Device Identification Necessitates Immediate Response Thu Jun 13 2013, 14:27 ET NeuroDerm Announces Presentation of ND0612 Phase 1 and Phase 2 Results at the 2013 International Congress of Parkinson's Disease and Movement Disorders Thu Jun 13 2013, 8:16 ET Magicool Plus® pioneering medical sprays now available on NHS Prescription and OTC Thu Jun 13 2013, 1:30 ET Abyrx,™ Inc. Receives FDA 510(k) Clearance for New Absorbable Hemostatic Bone Putty (AHBP™) Wed Jun 12 2013, 16:42 ET Approval Of Boston Scientific's Watchman Device Will Support Rapid Growth In The Global Heart Defect Closure Device Market Wed Jun 12 2013, 8:00 ET Dietary Supplement GMP Inspectional Readiness Virtual Conference Tue Jun 11 2013, 6:04 ET SanBio Announces FDA Clearance for the Initiation of a Phase I/2a Clinical Trial Testing Their Cell Therapy Product, SB623, in Patients with Traumatic Brain Injury Mon Jun 10 2013, 13:15 ET Cumberland Pharmaceuticals Reports FDA Approval For Updated Acetadote® Labeling Mon Jun 10 2013, 8:05 ET New Four-Strain Influenza Vaccine from Sanofi Pasteur Now Licensed By FDA for Broad Age Range of Children and Adults Mon Jun 10 2013, 7:00 ET The Leukemia & Lymphoma Society Applauds FDA's Approval of Lenalidomide for Patients with Relapsed or Refractory Mantle Cell Lymphoma Wed Jun 5 2013, 17:22 ET Actavis Confirms Generic Safyral® Patent Challenge Wed Jun 5 2013, 16:36 ET Avanir Pharmaceuticals Announces Accelerated Development Path for AVP-786 Following Successful Pre-IND Meeting with FDA Wed Jun 5 2013, 8:00 ET Kinex Announces that the US FDA Allows their IND to Begin KX02 Clinical Trials Tue Jun 4 2013, 9:00 ET Cochlear Americas Receives FDA Approval for the First and Only Ear Level Accessory for Waterproof Hearing with Cochlear Implants Fri May 31 2013, 13:07 ET Vanda Announces Submission To FDA Of A New Drug Application For Tasimelteon For The Treatment Of Non-24-Hour Disorder In The Totally Blind Fri May 31 2013, 6:55 ET Endo Pharmaceuticals Provides Regulatory Update On AVEED™ (Testosterone Undecanoate) Injection Thu May 30 2013, 16:17 ET AbbVie Announces Market Availability of New CREON® (pancrelipase) 36,000 Lipase-unit Capsules for Patients with Exocrine Pancreatic Insufficiency Thu May 30 2013, 8:15 ET Breathe Technologies Sleep System Receives FDA Clearance Thu May 30 2013, 6:00 ET Two new GSK oral oncology treatments, BRAF-inhibitor Tafinlar® (dabrafenib) capsules and the first MEK-inhibitor Mekinist™ (trametinib) tablets, approved by FDA as single-agent therapies Wed May 29 2013, 17:24 ET Perrigo Announces FDA Final Approval For Generic Equivalent To Sanctura XR® Wed May 29 2013, 7:54 ET TWi Pharmaceuticals' Manufacturing Site for the Generic Version of Lidoderm(R) (Lidocane 5% patch) Passes US FDA cGMP Audit and Pre-Approval Inspection Wed May 29 2013, 5:07 ET Oramed CEO to Present at New York Biotechnology Association and The Israel Conference's Fast & Cool™ Session Tue May 28 2013, 9:40 ET Neuralstem's Cells Induce Improvement In Acute Spinal Cord Injury Rats, UCSD Study Shows Tue May 28 2013, 9:15 ET Valeant Pharmaceuticals Announces Receipt Of U.S. FDA Complete Response Letter For Efinaconazole Tue May 28 2013, 7:00 ET Sensus Healthcare Receives FDA Clearance to Treat Keloids with the SRT-100™ Fri May 24 2013, 10:37 ET For breast cancer patients seeking a natural reconstruction, HydraSolve® liposuction from Andrew Technologies offers the first FDA-cleared option to provide your own fat for transfer Fri May 24 2013, 9:00 ET Press Statement on Behalf of the Singh Family (The Former Shareholders and Founders of Ranbaxy) Thu May 23 2013, 10:26 ET BioElectronics and Pulsed Shortwave Therapy Make Progress Thu May 23 2013, 8:30 ET Investigational New Drug Application Cleared by FDA for OMS824 in Huntington's Disease Thu May 23 2013, 7:00 ET Varian Medical Systems Receives FDA 510(k) Clearance of its Nexus DRF Digital X-Ray Imaging System Wed May 22 2013, 8:00 ET Bausch + Lomb Receives FDA Approval for the TRULIGN™ Toric Posterior Chamber Intraocular Lens Tue May 21 2013, 10:00 ET BioElectronics Presents FDA Reclassification Panel Tue May 21 2013, 8:30 ET Hologic Receives FDA Approval for a New Low-dose 3D Mammography (Breast Tomosynthesis) Solution for Breast Cancer Screening Tue May 21 2013, 8:15 ET Muscle Warfare a wholly owned subsidiary of Embark Holdings (EMBK) passes inspection by the FDA Mon May 20 2013, 7:00 ET New Study Shows Full Spectrum Endoscopy Procedure Reduces The 'Miss Rate' of Adenomas During Colonoscopy Sat May 18 2013, 10:00 ET FDA Sets 17 July 2013 For MOXDUO® Advisory Committee Meeting Fri May 17 2013, 9:00 ET Thoratec Announces FDA Approval Of HeartMate II® Pocket Controller™ Fri May 17 2013, 8:00 ET Oramed Receives FDA Clearance to Initiate Oral Insulin Trials in the U.S. Fri May 17 2013, 7:50 ET Mylan Launches Generic Tricor® Tablets Fri May 17 2013, 7:30 ET Syneron Introduces Enhancements to its Innovative Body Shaping Products Thu May 16 2013, 9:00 ET TaiGen Biotechnology Announces Submission of New Drug Application for Nemonoxacin in Taiwan and Mainland China Thu May 16 2013, 0:00 ET SIMPONI® (golimumab) Receives FDA Approval for Ulcerative Colitis Wed May 15 2013, 16:15 ET Mylan Launches Generic Zomig® Tablets Wed May 15 2013, 11:40 ET Bayer Receives U.S. FDA Approval for Xofigo® (radium Ra 223 dichloride) Injection as a New Treatment for Castration-Resistant Prostate Cancer with Bone Metastases Wed May 15 2013, 11:40 ET MiE's PET SCINTRON Receives FDA Approval Wed May 15 2013, 8:56 ET TWi Pharmaceuticals Announces Tentative ANDA Approval for Guanfacine Hydrochloride Extended-Release Tablets Tue May 14 2013, 7:54 ET < Prev Next >