In addition, Eisai must conduct a post-authorization safety study, including setting up a patient registry for the European Union. Now each European country must set its own rules for access and ...

Susan Aaron was an active 74-year-old retiree with Alzheimer’s who was told she might experience extreme fatigue and terrible headaches if she tried a new drug from Eisai Co. that promised to slow the ...

Eisai Co.’s breakthrough Alzheimer’s drug Leqembi was cleared for use in the European Union, after the medicine was approved in the US and Japan. The European Commission approved the drug to treat ...

The Trump administration is expected to announce tariffs on pharmaceuticals "in the next month or two," an official said. | The Trump administration is expected to announce tariffs on pharmaceuticals ...

Leqembi gains European approval after CHMP reversal, despite safety concerns tied to brain swelling and bleeding in Alzheimer ...

The European Commission on Tuesday authorized the use of Eisai and Biogen's drug to treat some patients with mild cognitive impairment in the early stages of Alzheimer's disease, ending a more than ...

Following the nod in the EU, BIIB & Eisai's Leqembi becomes the first therapy to slow the progression of early Alzheimer's ...

European regulators have finally approved the Alzheimer’s treatment Leqembi after an advisory committee initially rejected ...

CHMP reversed its initial recommendation for the EC to not authorize the drug due to the risk of side effects like ARIA.

After a lengthy regulatory back-and-forth, Eisai and Biogen's Alzheimer's drug is on the market in Europe. Elsewhere, Sarepta will start testing a new gene therapy for limb-girdle muscular dystrophy.

President Trump unveiled a wide-ranging executive order that aims to lower drug prices, boost transparency into fees charged ...