Biogen’s Aduhelm was the big one, but there are plenty of other key regulatory decisions still pending this year.
Worries about a stricter US FDA come to nothing, as last year’s approval total beats 2019’s.
Blockbuster sales are predicted for several projects nearing approval, from Biogen, Argenx, Fibrogen and others.
Few signs of a tightening regulatory climate can be found in approval numbers for 2020 – but some big decisions are still pending.
A clutch of swift FDA decisions boosted average US drug approval times in 2019, helping biopharma to deliver another bumper crop of new medicines.
With only 18 novel drugs approved by the FDA so far this year, the influential US regulator looks set to dim the green lights in 2019.
The commercial potential of last year’s new medicines suggests another strong year of productivity from biopharma, while a further analysis reveals the arrival of two…
Was 2018 as good as it gets for drug approvals, or is the pipeline so stellar that even a US government shutdown cannot stop biopharma?
Amid market volatility, biotech’s best friend comes through once again: the FDA has authorised a bumper 53 new medicines so far in 2018 and several more are expected…