Pain drugs look like they could face different outcomes, while targeted cancer agents will have a big month. Two biosimilar decisions also await.
October looks to be a big month for label expansions, with Dupixent and Hemlibra both poised to move into big new patient populations. Meanwhile Ionis is awaiting a…
Apple has obtained its first FDA clearance, putting the Apple Watch on the same footing as Alivecor’s KardiaBand – but the smaller group is fighting back.
Chi-Med is not alone in seeing Chinese approval as the prelude to a regulatory green light in the west.
As Brainsway pioneers a new option in obsessive compulsive disorder, Vantage looks at how these devices have moved into new indications over the past decade.
Alnylam has secured its first approval, but history suggests that launch will be far from easy.
Regulatory intervention having limited impact on fostering innovation.
The UK has voted to remain in the European Medicines Agency – and it will need to if it wants to avoid delays in drug approvals, data show.
If the US drugs regulator picks up the pace in the second half of the year, 2018 could be a bumper year for novel medicine approvals.