Another "approvable" for Advair Diskus
This article was originally published in Pharmaceutical Approvals Monthly
GlaxoSmithKline's Advair Diskus (fluticasone propionate/salmeterol inhalation powder) is "approvable" Dec. 12 for chronic obstructive pulmonary disease. A March 5 approvable letter requested more efficacy data and further safety data on long-term use in COP
You may also be interested in...
Device Week, 05 March - Remote Monitoring Reimbursement, T-cell Diagnostics And A Digital Health Feature
In this week's podcast, managing editor Marion Webb discusses a new monthly digital health roundup which will soon feature on Medtech Insight. Managing editor Reed Miller discusses reimbursement difficulties as it applies to remote cardiac monitoring. UK-based reporter Barnaby Pickering gives an overview of an interview with the chief medical officer of Adaptive Biotechnologies about its new T-Detect platform.
Coronavirus Notebook: Italy Makes First Use Of EU’s Vaccine Export Control System, More Regulators Issue Guidance On Variants
Ukraine has established a system for issuing emergency use authorizations for COVID-19 vaccines that recognizes authorizations granted by other world regulators.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.