Go or no go? Pandemic looms over FDA timelines
Approval decisions are due for Jazz, Gilead and Galapagos in July, while Glaxo is preparing for a panel.
US FDA approval tracker: several early decisions in May
Last month the FDA greenlit four oncology approvals early and the first GnRH antagonist in uterine fibroids.
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…
Lynparza’s prostate cancer surprise
An unexpectedly broad prostate cancer label gives the Parp inhibitor a strong advantage over Clovis’s rival Rubraca.
Go or no go? Oncology dominates upcoming decisions
Astrazeneca’s Lynparza is due US approval decisions in prostate and ovarian cancers, while Bristol's Opdivo’s fate will be determined in lung cancer.
Go or no go? Covid-19 upstages US regulatory decisions
A Vantage analysis of FDA decisions expected in the next month and how the ongoing Covid-19 pandemic could affect these.
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…
US FDA approval tracker: a first for Aimmune
January saw Aimmune receive an FDA approval for Palforzia, a first for peanut allergy, alongside decisions for Blueprint Medicines and Horizon Therapeutics.
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.
