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FDA News News from StratCenter.com News Archive

StratWire - Complete Business of FDA Newsfeed

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Page: 1 of 14 FDA News News from StratCenter.com

  1. FDA Enters Hurricane Fight
  2. FDA Asks for More Info on Dacogen Drug
  3. Market Pulse: MGI, SuperGen get FDA approvable letter for MDS treatment
  4. Approvable Letter Received from the FDA for Dacogen Injection for the Treatment of MDS
  5. Anika Ends Deal With J&J Unit
  6. Carrington Actively Coordinating Mouthwash Recall and Investigation With FDA and TX Dept of Health
  7. Par Pharmaceutical's Partner Receives Final Approval To Market Mirtazapine Orally Disintegrating Tablets
  8. Official Quits on Pill Delay at the FDA
  9. FDA Approves Drug Meant to Help Short Children Grow
  10. Amgen Announces FDA Licensure of 2 New Manufacturing Facilities
  11. Geron: Studies Show Slowed Tumor Growth
  12. Market Pulse: Barr inks deal w/ Teva for generic version of Allegra
  13. Teva and Barr Announce Launch of Generic Allegra Tablets by Teva Under Agreement With Barr
  14. AMBIEN CR CIV Receives FDA Approval for the Treatment of Insomnia
  15. MGI Pharma's Dacogen Likely Approved In Q1 2006
  16. VA Pittsburgh Healthcare System To Ink Deal With J&J
  17. Minneapolis VAMC Seeks Immunoassay Reagents for use with Immulite
  18. BIOLASE Announces 510k FDA Submission of Its OCULASE MD for Ophthalmology
  19. Cephalon Files New Drug Application for OraVescent Fentanyl for the Mgmt of Breakthrough Pain in Cancer Patients
  20. ViaCell Appoints Anne Marie Cook as General Counsel
  21. Bristol-Myers Squibb Statement on FDA Advisory Committee Vote on ORENCIA, an Investigational Selective Modulator of T-Cell -Stimulation for Rheumatoid Arthritis
  22. Diagnostic Products Corp Released from FDA's Application Integrity Policy
  23. Avalon Pharmaceuticals Announces Filing of IND for AVN944 for the Treatment of Cancer
  24. Study Shows That HyperQ Stress System From BSP can Help Detect Ischemic Heart Disease
  25. Digene Initiating Direct-to-Consumer Television Advertisements in 2 New Metropolitan Areas
  26. Manufacturing violations could idle Andrx
  27. CardioTech Stock Up on FDA Device Approval
  28. Market Pulse: IntraLase receives FDA OK for expanded use of laser tech
  29. Genentech's Lucentis Denied Fast-Track
  30. FDA Expands IntraLase FS30 Laser Use to Include Penetrating and Lamellar Corneal Resections
  31. Market Pulse: Sepracor: FDA gets ANDA for generic Xopenex inhalation
  32. Sepracor Receives Notice of Abbreviated New Drug Application Submission for Levalbuterol Hydrochloride Inhalation Solution
  33. Caremark Rx to Present at the Thomas Weisel Partners Healthcare Tailwinds Conference 2005
  34. Physician at Long Beach Memorial to Implant World's 1st FDA-Approved Artificial Spinal Disc - Will Help Thousands With Back Problems
  35. FDA Approves ThinPrep Pap Test Expanded Labeling for Detection of Glandular Lesions
  36. Bedford Labs Further Expands its Oncology Offerings
  37. Celgene Stock Dips Ahead of Revlimid Panel
  38. Abbott Labs' Xinlay Rejected by Panel
  39. Sandoz Files Lawsuit Seeking FDA Ruling on Omnitrope
  40. Genzyme Starting New Myozyme Study
  41. Applied Digital to Present at 2nd Annual Merriman Curhan Ford &. Investor Summit on 9/19/2005
  42. 21st Century Health Care Terrorism - The Perils of Int'l Drug Counterfeiting
  43. Teva Announces Tentative Approval of Ribavirin Tablets
  44. Boston Scientific wins approval for new coronary device
  45. FDA Approves REMICADE as 1st and Only Biologic to Treat Ulcerative Colitis
  46. Boston Scientific Receives FDA Clearance for Flextome Cutting Balloon Dilatation Device
  47. Ranbaxy Receives Tentative Approval to Market Tolterodine Tartrate Tablets
  48. Ranbaxy Receives Final Approval for Gabapentin Tablets
  49. Market Pulse: Boston Scientific gets marketing ok for Flextome from FDA
  50. Macugen Receives Positive Opinion for Treatment of Neovascular Age-Related Macular Degeneration from the European Medicines Agency
  51. Fougera Receives 1st Tentative Generic Approval for MetroGel
  52. Market Pulse: Teva receives tentative FDA approval for Ribavirin
  53. NMT Medical Announces IDE Approval to Begin MIST II Pivotal Migraine Study in the US
  54. MedImmune Submits Refrigerator-Stable Formulation of FluMist to FDA for Approval in Healthy Individuals 5 to 49 Years of Age
  55. Valeant Pharmaceuticals Unveils Diastat AcuDial for Safe, Rapid At-Home Treatment of Emergency Seizures
  56. StemCells amends FDA application
  57. Pfizer Injectable COX-2 Not Approvable
  58. CoolTouch wins FDA OK for new vein treatment
  59. Ranbaxy Receives Approval to Market Zidovudine Tablets
  60. FDA Approves 1st Pediatric Generic AIDS Drug for US Marketing
  61. Alnylam Accelerates RSV Infection Program and Provides Update on AMD Program
  62. NeoPharm to Present at UBS 2005 Global Life Sciences Conference
  63. FDA Accepts filed Pre-Market Approval Supplement to Expand the Indication for Hyalgan to Include Shoulder Pain Due to Osteoarthritis
  64. Top Universities to Test New Technology Targeting Prostate Cancer
  65. Medtronic announces release of spinal fusion product
  66. Ranbaxy gets FDA OK for HIV drug
  67. Xoma signs agreement for hep b trials
  68. FDA: Inamed Breast Implants 'Approvable'
  69. Baxter's February 2005 ive Action for COLLEAGUE Infusion Pump Receives FDA Class I Designation
  70. Hampton VAMC To Ink Deal With J&J for OTW Cypher Sirolimus-eluting Stents
  71. Taro Gets FDA OK for Generic Bactroban
  72. Taro Receives Approval For Mupirocin Ointment USP, 2% ANDA
  73. HCRI Announces Departure of Founder, Creation of Chief Academic Officer Position
  74. Facility Expands Scope of HGS
  75. Regulators place hold on ViaCell clinical trial
  76. Edwards makes heart valve debut in Europe
  77. Dr Throckmorton Appointed Deputy Dir of FDA’s Center for Drugs
  78. Positive Data Leads to FDA Approval for Early Termination of Essure Post-Approval Study
  79. Market Pulse: King Pharma: FDA accepts supplemental NDA filing for Altace
  80. TriPath Imaging Withdraws PMA Supplement Submission
  81. Vivus Meets With FDA Over Libido Spray
  82. Cubist seeks expanded use of antibiotic Cubicin
  83. Market Pulse: Sanofi Pasteur files w/ FDA for Pentacel combination vaccine
  84. Market Pulse: Cubist applies for 2nd FDA approval of Cubicin
  85. Cubist Submits New Cubicin Application
  86. Cubist Pharmaceuticals Files sNDA to Expand CUBICIN Label for Staphylococcus Aureus Bacteremia With Known or Suspected Endocarditis
  87. Biogen, Elan Submit Tysabri Application
  88. Market Pulse: Biogen, Elan file supplemental Tysabri application for MS
  89. Biogen Idec and Elan Submit Supplemental Biologics License Application to the FDA for TYSABRI in Multiple Sclerosis
  90. Halozyme Therapeutics Provides Update on Hylenex New Drug Application
  91. FDA Accepts for Filing License Application for New Pediatric Combination Vaccine, PENTACEL
  92. FDA tells TriPath that new data is needed for device approval
  93. EMEA Grants Orphan Drug Designation to Troxatyl for the Treatment of Acute Myeloid Leukemia
  94. Healthcare Professionals Alerted to Reported Medication Errors Between TOPAMAX and TOPROL-XL
  95. BD Diagnostics Announces FDA 510 Clearance of BD Directigen EZ Flu A+B Test
  96. LMS risk mgmt tool, CALM Patterns, to receive European CE Mark clearance
  97. Market Pulse: Insmed: FDA completes review of iPlex new drug application
  98. Insmed Receives Approvable Letter for iPlex
  99. Pfizer: FDA OKs Lipitor for Stroke
  100. FDA Approves Lipitor to Reduce Stroke Risk