Senate Dems Walk Out of Committee Vote on Tom Price, Delaying Confirmation February 7, 2017 Democratic members said they would not vote until they received more information on Price’s stock purchases. Read More
FDA Approves Lower Dose of Adapt Pharma’s Overdose Therapy Narcan February 6, 2017 The dose is indicated for patients at risk for severe opioid withdrawal. Read More
Teva Secures FDA Approval for Two Asthma Combination Products February 6, 2017 AirDuo RespiClick, is similar to GlaxoSmithKline’s Advair inhaler. Read More
FDA Approves New Dose for Linzess for Chronic Idiopathic Constipation February 3, 2017 The product is now FDA-approved in three dosage strengths. Read More
Swissmedic Plans to Concentrate on Adverse Drug Reports from Sponsors February 2, 2017 The Swiss agency has seen a significant increase in AER submissions. Read More
Novartis Withdraws Zioxtenzo Application February 2, 2017 The sponsors withdrew the application based on study results. Read More
FDA Approves Synergy’s Once-Daily Trulance for Chronic Constipation January 27, 2017 Patients receiving Trulance were more likely to improve. Read More
FDA Grants Accelerated Approval to Imbruvica in Marginal Zone Lymphoma January 26, 2017 The agency granted an accelerated approval based on improvements in overall response rate. Read More
FDA Approves Generic Version of Narcolepsy Drug Xyrem with REMS January 25, 2017 The generic is also approved to treat patients who suddenly lose muscle tone and control while awake. Read More
FDA Extends Review Period for Baricitinib January 25, 2017 The FDA extended the action date to allow time to review additional data analyses. Read More
Lysogene’s Drug Candidate Receives Pediatric Disease Designation January 24, 2017 LYS-GM101 has the potential to replace the defective gene in the cells of GM1 patients. Read More
FDA Awards Fast Track Designation to aTyr’s Resolaris January 23, 2017 The FDA also lifted its partial clinical hold on a dosing limit for Resolaris in clinical trials. Read More