FDA: Basic Research Needed to Hasten Cures for Certain Diseases July 23, 2015 The agency wants increased focus on the underlying biology of Alzheimer’s and diabetes, among others. Read More
Carestream Launches Two Radiographic Systems Globally July 22, 2015 The DRX-Excel and the DRX-Excel Plus can be used for general radiography and fluoroscopic sequences imaging. Read More
FDA, Google Meet About Tracking Adverse Drug Reactions July 22, 2015 The agency is turning to the web to broaden its search. Read More
Cytox, Affymetrix Forge Strategic Partnership to Develop Alzheimer’s Genetic Assay July 21, 2015 The blood-based test would be used for research into the diagnosis and prognosis of the disease. Read More
PDUFA VI Negotiations Commence July 21, 2015 The FDA wants to use new drug application fees to boost Sentinel’s capacity. Read More
Valencia Technologies Gains Two Patents for New Technology July 20, 2015 The patents are for the company’s tiny, leadless neurostimulator. Read More
FDA Puts One More Indian Drugmaker on Import Ban List July 20, 2015 The agency found Emcure Pharmaceuticals’ Hinjewadi, Maharashtra, India, facility in violation of good manufacturing practices. Read More
Magellan Diagnostics’ Blood Lead Testing System Secures FDA Clearance July 17, 2015 The LeadCare Plus is meant for routine testing in children. Read More
FDA OKs AstraZeneca’s Iressa for First-Line Treatment of Metastatic Lung Cancer July 17, 2015 The drug has orphan product designation, giving it six years of marketing exclusivity. Read More
St. Jude Medical Wins FDA Nod for Spinal Cord Stimulator July 16, 2015 The product incorporates Apple products and Bluetooth wireless technology. Read More
FDA to Mandate Stronger Heart Attack and Stroke Warnings on NSAID Labels July 16, 2015 The move comes after a comprehensive review of new safety information affirmed an increased risk of heart attack or stroke. Read More
Luminex Submits FDA 510(k) Application for Aries Products July 15, 2015 The application is for a molecular diagnostics platform and a herpes simplex virus 1&2 assay. Read More