Go or no go? Aducanumab’s day of reckoning
Next month the FDA will determine Biogen’s fate in Alzheimer’s, while Ascendis and Novo Nordisk also await Pdufa decisions.
Go or no go? Oncology decisions ahead for the FDA
The US regulator will provide verdicts on cancer projects from TG and Athenex, while Sarepta aims for its third Duchenne approval.
Has 2020 been a big year for regulatory knockbacks?
An analysis of FDA complete response letters does not reveal a big uptick – but the year is not over yet.
Go or no go? A quiet month ahead for US approval verdicts
A decision is due on Bristol’s new leukaemia project, while Mallinckrodt and Mesoblast await their fates after mixed panel meetings.
Biotech’s balancing act amid Covid-19 delays
A Vantage analysis suggests which small biotechs might seriously have to rethink R&D spending plans in the wake of Covid-19.