Go or no go? J&J’s bispecific FDA first
Pdufa decisions also beckon for Amicus, Acadia and Bluebird.
Go or no go? FDA firsts for Imfinzi, Enhertu and roflumilast
Assets in oncology and psoriasis are set for upcoming Pdufa decisions.
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? 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.