Cytokinetics aims to become the Vertex of cardiovascular disease
But a surprise adcom for omecamtiv mecarbil might put a spanner in the works.
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.
The Covid vaccine battleground gets younger
The FDA has finally confirmed the date of a review of Covid vaccine data in the very young, but has Pfizer/Biontech already won the race?
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.
Is biopharma getting better at accelerated approval conversions?
Amid ongoing pressure to reform the FDA’s fast-track pathway, signs emerge that the criticism is being heard.
