Go or no go? Pandemic looms over FDA timelines
Approval decisions are due for Jazz, Gilead and Galapagos in July, while Glaxo is preparing for a panel.
Go or no go? A busy month ahead for US FDA decisions
June will be hectic for the US regulator, with many approval decisions due, including one for subcutaneous Arzerra in multiple sclerosis and Tazverik in follicular…
Astra could use a voucher to cement roxadustat’s head start
Spending $95m to speed up the anaemia project’s path to approval could be worth the investment for Astrazeneca.
Another knock back for urea cycle disorders
Curevac’s decision to exit work on an mRNA approach to OTC deficiency follows a clinical hold on Translate Bio’s similar project, and raises broader concerns.
Neuren pays the price for sellside froth
The Australian group has found a partner for its lead asset at last, so why is the stock down?
