FDA Awards Priority Voucher for Rare Pediatric Disease Designation to Alexion November 20, 2015 Strensiq is a long-term enzyme replacement therapy to treat infantile and juvenile onset hypophosphatasia. Read More
St. Jude Medical Wins FDA Approval for Spinal Cord Stimulation System November 19, 2015 The device contains a non-rechargeable system and an upgradable platform. Read More
FDA Expands Label of Gilead’s Harvoni November 19, 2015 The indication is expanded to patients with genotype 4, 5 and 6 chronic hepatitis C virus infection and in patients co-infected with HIV. Read More
Moximed Wins CE Mark for Atlas Knee System November 18, 2015 The device is a next-generation knee joint unloader for pre-arthroplasty patients. Read More
Leo Pharma Purchases Astellas’ Dermatology Business November 18, 2015 The transaction is valued at $727 million. Read More
Innovacyn’s Puracyn Plus Professional Formula Wins Canadian Approval November 17, 2015 The formula is designed to improve preparation of the wound bed. Read More
VA Appropriations Bill Passes Senate With Funding for HCV Treatments November 17, 2015 The bill awards $900 million for hepatitis C virus treatments. Read More
Perspectum Wins 510(k) Clearance for LiverMultiScan Imaging Device November 13, 2015 The device can detect early liver disease using MRI. Read More
FDA Grants Tentative Approval to Collegium’s Xtampza ER November 13, 2015 The drug is subject to an automatic stay of up to 30 months due to patent litigation filed by Purdue Pharma. Read More
MedCurrent to Launch Radiology Decision Support System November 12, 2015 The new version features updated interfaces to interfaces to streamline efficiency for radiology departments and imaging centers. Read More
Pfizer Recalls Lot of Xanax Over Out of Specification Result November 12, 2015 The affected Xanax lot was shipped to pharmaceutical distributor Besse Medical between August 2011 and March 2012. Read More
Medtronic Announces Results of Pacing System Trial November 11, 2015 The Micra transcatheter pacing system met its safety and effectiveness endpoints in a clinical trial. Read More