ICER has also reiterated its position that the evidence that Leqembi (lecanemab ... incomplete understanding of the underlying molecular mechanisms that could be targeted with disease-modifying ...

Biogen BIIB and Japan-based partner, Eisai, announced an update regarding the regulatory review of an application seeking the ...

An effort two decades in the making, Vertex Pharmaceuticals Inc.’s suzetrigine gained U.S. FDA approval as the first drug targeting the NaV1.8 pain signal. Branded Journavx, the oral small molecule is ...

EMA approval of the Alzheimer’s disease therapy Leqembi (lecanemab) has stalled once again, after the European Commission did not as usual nod through the agency’s recommendation, but told it to ...

LEQEMBI is indicated for the treatment of ... can negatively impact cognitive function via multiple mechanisms, not only increasing the development of insoluble Aβ plaques but also increasing ...

The European Medicines Agency (EMA) announced it will review new safety data on the Alzheimer’s disease drug Leqembi (lecanemab). This follows a prior decision to recommend its use in the ...

EMA changes tune, endorses Eisai and Biogen's Leqembi in restricted Alzheimer's population That trio of molecules stands out in the late-stage pipeline because of their novel mechanisms ...