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…
Go or no go? Ozanimod and Fintepla await FDA verdicts
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…
Zogenix hands GW a win
A phase III Lennox-Gastaut trial sees Fintepla meet statistical significance but fail the test of clinical relevance.
Go or no go? Esperion's double whammy and a look to priority reviews
Four assets with previous rejections are due FDA decisions in February, while those with priority review could become the next string of early approvals.
Upcoming events – Genmab's route to market, and late-stage data for Zogenix
Genmab is seeking data to position tisotumab as its first in-house launch, while Zogenix wants Fintepla to challenge GW in Lennox-Gastaut syndrome.
Zogenix gets an unwelcome distraction from Fintepla
Spending $250m on Modis gives Zogenix a new rare disease niche, but the timing and the target both look odd.
