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
FDA Rejects Tesaro’s Rolapitant IV January 20, 2017 The FDA requested additional information on the in vitro method. Read More
FDA Grants QIDP and Fast Track Designations to RedHill’s Mycobacteria Antibiotic January 20, 2017 The course of treatment is typically prolonged and requires multi-drug regimens. Read More
FDA Urges Sponsors to Minimize Design Changes in Generic Drug Delivery Products January 20, 2017 The agency may accept design differences if they are adequately analyzed and scientifically justified. Read More
FDA Grants Orphan Drug Designation to Acucela’s Emixustat Hydrochloride January 19, 2017 The product is designed to modulate the visual cycle by inhibiting an enzyme related to the processing of Vitamin A. Read More