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…
Big approval decisions pending in March include ozanimod in multiple sclerosis, where Bristol-Myers is likely to win a green light, while the safety of Zogenix's…
A phase III Lennox-Gastaut trial sees Fintepla meet statistical significance but fail the test of clinical relevance.
Four assets with previous rejections are due FDA decisions in February, while those with priority review could become the next string of early approvals.
Genmab is seeking data to position tisotumab as its first in-house launch, while Zogenix wants Fintepla to challenge GW in Lennox-Gastaut syndrome.
Spending $250m on Modis gives Zogenix a new rare disease niche, but the timing and the target both look odd.