Regulatory

Found 23,263 articles

• Novartis Corporation Release: New Drug Application For Galvus(R), An Innovative Oral Therapy For People With Type 2 Diabetes, Accepted For Review By FDA

  3/29/2006

• Pharmion Corporation Announces Submission Of Vidaza NDA Supplement For IV Administration

  3/29/2006

• Amgen And Abgenix Complete Biologics License Application For FDA Approval Of Panitumumab

  3/29/2006

• PTC Therapeutics, Inc. Receives Fast Track Designation For PTC124 In The Treatment Of Duchenne Muscular Dystrophy

  3/29/2006

• Cynosure, Inc. Receives Additional FDA Clearance For Pulse Dye Laser

  3/29/2006

• Axcan Pharma Submits FDA Amendment To Its New Drug Application For HELIZIDE

  3/28/2006

• Depomed, Inc. And Madaus S.r.l. Announce Acceptance Of The Application For Approval Of ProQuin(R) XR In Sweden

  3/28/2006

• Medical Services International Inc. To Apply For CE Approval In Europe

  3/28/2006

• Cephalon, Inc. Granted Six Months Of Pediatric Exclusivity For PROVIGIL(R)

  3/27/2006

• Inspire Pharmaceuticals Announces Outcome Of FDA Meeting On Dry Eye Program; Additional Information To Be Provided To FDA As Next Step

  3/27/2006

• FDA Issues Approvable Letter For Cubist Pharmaceuticals, Inc.'s CUBICIN sNDA

  3/26/2006

• Wex Pharmaceuticals Inc. Announces Manufacturing Inspection Report

  3/26/2006

• Reliant Technologies Announces FDA Clearance Of The Fraxel(R) Laser For The Treatment Of Acne And Surgical Scars

  3/26/2006

• Encysive Pharmaceuticals Shares Fall After FDA Asks For More Clinical Trial Data For Thelin Approval

  3/26/2006

• Cephalon, Inc. Release: FDA Advisory Committee Recommends Against Approval Of SPARLON(TM) For Attention Deficit/Hyperactivity Disorder In Children And Adolescents

  3/24/2006

• EU Panel Rejects Novartis Pharma AG's Bowel Drug, Backs Shingles Shot

  3/24/2006

• Synovis Life Technologies Ends Enrollment In Colorectal Study

  3/24/2006

• Aastrom Biosciences, Inc. Receives Orphan Drug Designation From The FDA For Proprietary Bone Marrow Cells

  3/24/2006

• BSD Medical Applies For FDA Approval Of The BSD-2000 Cancer Treatment System

  3/24/2006

• Advisers Reject Strong ADHD Warnings

  3/23/2006