Pdufa decisions also beckon for Amicus, Acadia and Bluebird.
But progress – or lack thereof – with lenacapavir is a more immediate concern.
Increased headcount should allow the FDA to up the number of approvals – but not quite yet.
Getting the Swiss firm’s Beigene-derived anti-PD-1 MAb across the US finish line is proving harder than expected.
Assets in oncology and psoriasis are set for upcoming Pdufa decisions.