The EC requests CHMP to reassess new safety data that emerged after the positive opinion recommending the approval of ...

The European Commission has requested its medicines regulator to consider safety information on Eisai and Biogen's ...

Biogen (BIIB) stock in focus as company and partner Eisai (ESALF) face delay in the EU launch of Alzheimer's drug lecanemab.

European Union regulators will review new information relating to the safety of Eisai Co.’s and Biogen Inc.’s medicine for ...

The U.S. Food and Drug Administration has approved monthly maintenance dosing for Japan's Eisai and partner Biogen's ...

In a good-news-bad-news week for Biogen, the company will cut an undisclosed number of employees, just as a higher dose of its Ionis-partnered therapy Spinraza for spinal muscular atrophy will be ...

Sage Therapeutics has rejected the unsolicited acquisition offer it received earlier this month from longtime partner Biogen ...

Also, concerns about the efficacy of both drugs was brought up by both FDA scientist and advisory committee members. OIG also noted that in the case of aducanumab, Biogen's meetings with the ...

BIIB's regulatory filings are supported by late-stage data, which show that treatment with a higher Spinraza dose improves motor function in infants with SMA.

Biogen and Eisai’s Alzheimer’s disease (AD) drug Leqembi (lecanemab-irmb) has been approved by the US Food and Drug ...

The 12-month price targets, analyzed by analysts, offer insights with an average target of $214.78, a high estimate of ...

Japanese pharmaceutical company Eisai Co. and U.S. firm Biogen Inc. said Monday that a jointly developed Alzheimer's drug has ...