Go or no go? The FDA’s Amylyx dilemma
June will see adcoms aplenty, with Bluebird, Acadia, and the Covid vaccine makers Novavax, Pfizer/Biontech and Moderna all facing FDA committees.
Go or no go? Lilly’s valuable diabetes contender
Tirzepatide heads for its first FDA approval and Enhertu eyes an earlier setting, as Verrica and Axsome keep their fingers crossed.
Go or no go? Bristol's first-in-class hopes
April should mark the approval of some of the biggest drugs of 2022, including Alnylam's vutrisiran, while TG will hope to be spared pain at the PI3K adcom.
Go or no go? Bristol’s Lag3 debut
March Pdufa dates are set for relatlimab as well as Akebia’s vadadustat, while Amylyx’s ALS drug heads for a panel.
Days of reckoning for immune checkpoint blockers
Can a trial carried out in China back a US approval? Investors in anti-PD-(L)1 players will find out soon enough.
