An analysis of FDA complete response letters does not reveal a big uptick – but the year is not over yet.
A shock US rejection delays approval by at least two years and makes Abbvie, which had given up rights five years ago, look smart.
Upcoming US approval verdicts include inclisiran, valrox and risdiplam, but toxicity issues could scupper filgotinib.
Approval decisions are due for Jazz, Gilead and Galapagos in July, while Glaxo is preparing for a panel.
With a $3.2bn valuation ahead of its Nasdaq float – and a market cap that is now 50% higher – Legend Biotech enters the IPO record books.