EMA to Overhaul EudraVigilance System for Monitoring Adverse Events November 3, 2015 The overhaul is designed to help the system comply with new postmarketing clinical trials legislation. Read More
Mainstay Medical Submits CE Mark Application for ReActiv8 November 2, 2015 ReActiv8 is an implantable neurostimulation system to treat disabling chronic low back pain. Read More
Shire to Submit New Study Results After Lifitegrast Snub November 2, 2015 The results could put the dry eye disease drug on track to enter the U.S. market next year. Read More
Integrity Applications Advances in FDA Approval Process for GlucoTrack October 30, 2015 The parties met to discuss clinical trial protocol. Read More
Merck’s Lung Cancer Drug Shows Survival Benefit in Study October 30, 2015 The phase 2/3 trial met primary survival endpoints. Read More
Sandomedics Gets Approval for Sale of Thermomedics Subsidiary, Acquires Brace Shop October 29, 2015 The sale of the subsidiary is valued at up to $2 million. Read More
FDA Approves Iroko’s Osteoarthrosis Drug October 29, 2015 Vivlodex is the first FDA-approved low-dose, rapid-dissolution meloxicam. Read More
Cynosure Wins Health Canada Approval for MonaLisa Touch Laser Procedure October 28, 2015 The laser is designed to treat symptoms related to Genitourinary Syndrome of Menopause. Read More
Allergan, Endo Clarify Specialty Pharmacy Use Following Valeant Controversy October 28, 2015 Allergan says it doesn’t rely on specialty pharmacies to distribute its products. Read More
Endologix, TriVascular Technologies Announce Merger October 27, 2015 The cash and stock transaction is valued at around $211 million. Read More
FDA Approves Relypsa’s Hyperkalemia Therapy Veltassa October 27, 2015 The approval marks the first advance in treating the life-threatening condition in more than five decades. Read More
Mach7 Technologies, 3D Medical Merge October 26, 2015 The companies signed a definitive agreement. Read More