Keeping Track: CDER Novel Approvals Reach 11 With Corlanor In Busy Week For CV Drugs
Executive Summary
Weekly column reviews the latest drug development news from our FDA Performance Tracker. This week: updates on Amgen's Corlanor, ARCA biopharma's Gencaro and Aeterna Zentaris' Macrilen
You may also be interested in...
PTC’s Upstaza Takes Gene Therapy Straight To Brain (And US FDA); Translarna To Return Mid-Year
In a year full of regulatory milestones for the firm, PTC Therapeutics hopes to set some approval precedents – and basically hopes its candidates have an easier time of it than they have had before.
BeiGene’s Tevimbra And The End Of The COVID Inspection Era
US FDA approves the PD-1 inhibitor 20 months after user fee goal, resolving one of the last applications delayed by China’s extended pandemic travel restrictions.
Novo Nordisk’s Semaglutide Achieves ‘Cardiodiabesity’ Label
With Wegovy’s new indication for cardiovascular risk reduction in patients with overweight and obesity, the migration of diabetes drugs from a single disease state to address a host of interrelated conditions reaches a new milestone.