FDA Announces Priority Review Vouchers for Two Pediatric Disease Therapies April 10, 2015 The therapies treat cancer and a severe metabolic disorder. Read More
IV Monitoring Device Wins FDA Nod April 9, 2015 The device is the first of its kind capable of continuously monitoring peripheral IVs. Read More
Accutane’s Warning Labels Enough, Judge Rules April 9, 2015 The judge resolved suits filed by New Jersey residents who claimed the drug caused inflammatory bowel disease Read More
Perseon's MicroThermX Wins FDA Nod for Laparoscopic Ablation Procedures April 8, 2015 The device uses precision-guided microwave energy to ablate cancerous soft tissue. Read More
FDA Lengthens Comment Period on New Biomarkers April 8, 2015 Companies now have until May 15 to weigh in. Read More
Robotic Glove Developed to Help Stroke Victims April 7, 2015 The glove provides victims with exercises and games designed to counteract rigid, fixed- hand and -wrist postures. Read More
Federal Appeals Court Permits Apotex to Contest First-Filer Exclusivity With Patent Suit April 7, 2015 The appeals court reversed a lower court decision dismissing Apotex's lawsuit. Read More
FDA Expands Indication for Ethicon’s Bleeding Control Sealant Patch April 6, 2015 In clinical trials, devicemaker claims Evarrest showed 94 percent efficacy against the standard of care’s 53 percent. Read More
EMA Fees Lower Slightly Due to Inflation Rate April 6, 2015 The change is part of an annual adjustment that reflects the previous year’s inflation rate. Read More
FDA Grants Bruker’s MALDI Biotyper CA System Second, Expanded Claim April 3, 2015 The system has the highest bacterial and yeast identification rates of its kind. Read More
EMA Picks Influenza Vaccine Strains for Next Flu Season April 3, 2015 Manufacturers have until June 15 to submit their strain variation applications. Read More
Alere Wins FDA Nod for i Strep A Test April 2, 2015 The test is the first of its kind to detect Group A Strepotococcus bacteria in throat swab specimens in eight minutes or less. Read More