Go or no go? Roche’s fresh start for a new year
2022 kicks off with key FDA decisions for Roche, Novartis and Pfizer, while Astrazeneca hopes to extend Lynparza even further.
Go or go go? J&J’s cell therapy heads to the FDA
November approval decisions loom for cilta-cel and Voxzogo, while molnupiravir heads for an advisory panel.
Go or no go? August FDA decisions for Axsome, Sanofi and Merck
Axsome and Sanofi face FDA verdicts in depression and Pompe disease respectively, while a Keytruda combo ups the ante in kidney cancer.
Go or no go? Aducanumab’s day of reckoning
Next month the FDA will determine Biogen’s fate in Alzheimer’s, while Ascendis and Novo Nordisk also await Pdufa decisions.
Go or no go? Apellis and Heron head for the finish line
May will see US FDA decisions for Apellis, Heron and Bristol Myers Squibb, while Provention Bio is set for a panel meeting.
