FDA Awards BMS’ Opdivo Breakthrough Therapy Designation September 22, 2015 The designation entitles the company to more frequent meetings with the FDA. Read More
Circa Reaches Agreement with Magnet Group for Esophageal Temperature Probe September 21, 2015 The agreement allows participating healthcare facilities to purchase the system. Read More
FDA Adcom Offers Support for CSL’s Influenza Vaccine Fluad September 21, 2015 If approved, Fluad would become the first adjuvanted seasonal influenza vaccine for adults 65 and older in the U.S. Read More
Cynosure Receives China Clearance for Tattoo Removal Device September 18, 2015 The device results in greater disruption of the target with fewer treatments. Read More
Sanofi Diabetes Drug Meets Primary Endpoint in Phase 3 Trial September 18, 2015 LixiLan showed a greater drop in average blood glucose in diabetes patients when combined with Lantus. Read More
Philips and Radbound University Medical Center Launch Diabetes App September 17, 2015 The app enables patients and health providers to manage self-care. Read More
Amgen Seeks Approval for Monthly Dosage of Repatha September 17, 2015 Amgen recommends the 420 mg dosage for patients with HoFH. Read More
Bioness Announces First Procedure of StimRouter Neuromodulation September 16, 2015 The system treats chronic pain of peripheral nerve origin. Read More
FDA Accepts First-Ever Digital Medicine NDA September 16, 2015 The combination embeds an ingestible Proteus sensor in Otsuka’s Abilify. Read More
ViewRay Has First International Installation of MRIdian System at Korean Hospital September 15, 2015 The MRI-guided radiation therapy system will be used on patients in next few weeks. Read More
Concordia to Acquire Amdipharm Mercury for $3.5 Billion September 15, 2015 The acquisition gives Corcordia access to AMCo’s portfolio of more than 190 off-patent molecules. Read More
Medtronic Receives FDA Approval for Implantable Cardioverter Defibrillator System September 14, 2015 Patients in the U.S. who depend on ICDs now have access to MRI scans if and when they need them. Read More