Quidel Receives FDA Clearance for Molecular Test to Detect Herpes Viruses May 16, 2014 Device will detect the Herpes Simplex Virus 1 and 2 and Varicella Zoster Virus. Read More
EC Gives Marketing Authorization to Hepatitis Drug Olysio May 16, 2014 Part of a combo therapy, the drug provides a triple treatment option depending on the patient’s condition. Read More
MedImmune and Incyte to Collaborate on Immuno-Oncology Combination Clinical Trial May 15, 2014 Drugs hope to enhance anti-tumor immune system response. Read More
Medical Equipment Providers Charged in $13 Million Medicare Scam May 15, 2014 Fake Brooklyn companies submitted claims to a state-sponsored managed care group. Read More
Guided Therapeutics to Submit PMA Amendment for LuViva Cervical Scan May 14, 2014 The amendment addresses concerns in a 2013 not-approvable letter. Read More
Roche Gains EU Approval for New Subcutaneous Formulation of RoActemra May 14, 2014 Will provide treatment flexibility for patients with moderate to severe rheumatoid arthritis. Read More
Advanced Bionics’ Neptune Cochlear Implant Gains Japanese Approval May 13, 2014 Waterproof sound processor allows for wear while swimming or bathing. Read More
Merck to Sell Its Ophthalmology Portfolio to Santen May 13, 2014 Divested its U.S. ophthalmology business to Akorn in 2013 and 2014. Read More
FDA Clears Jintronix’ Motion Capture Rehabilitation System May 12, 2014 The Microsoft Kinect-based system will launch this fall. Read More
Tesaro Sees Positive Results in Final Phase 3 Trial of Rolapitant May 12, 2014 The company hopes to submit its NDA in mid-2014. Read More
FDA to Hold Workshop on Proteomics in the Clinic May 9, 2014 Public workshop to take place on June 13 at the FDA’s Silver Spring campus. Read More
H. Lundbeck to Purchase Chelsea Therapeutics for $658 Million May 9, 2014 Deal will add Northera (droxidopa) to Lundbeck’s portfolio of neurologic drugs. Read More