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.
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.
Ash 2019 – former Celgene holders look anxiously at contingent value
Celgene CVR holders have been desperate to find out whether JCAR017 is approvable. Yesterday at Ash they got their answer... kind of.
Go or no go? Vascepa’s finale and Allergan's pain relief
Amarin’s Vascepa and Allergan’s migraine project ubrogepant are the high-profile pending FDA approval decisions as the sector heads into the last month of the year.
Astra could use a voucher to cement roxadustat’s head start
Spending $95m to speed up the anaemia project’s path to approval could be worth the investment for Astrazeneca.
