Keeping Track: Novel Approvals Break Annual Records
Executive Summary
The latest drug development news and highlights from our FDA Performance Tracker.
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Biologics’ Big Bang: Novel BLAs Balance Breakthroughs And ‘Biobetters’
Both FDA’s biologics and drug centers posted historic BLA approval counts in 2014, combining to clear 21 novel biologics. The class is split between medical breakthroughs and “biobetters” offering incremental improvements, illustrating the maturation of the biotech industry.
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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.