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? 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? Enhertu’s destiny revealed and FDA decisions due for Epizyme, Novo
Enhertu gets an early thumbs up from the FDA – now decisions are due for Epizyme’s tazemetostat and Novo Nordisk's Rybelsus and Ozempic.