BioSpace18h
As US Sales of Leqembi Lag, Eisai Eyes SubQ Approvals
The FDA last month accepted the application for subcutaneous Leqembi for maintenance dosing, with a target action date of ...
Biogen Stock Down on Regulatory Update in the EU for Alzheimer's Drug
The EC requests CHMP to reassess new safety data that emerged after the positive opinion recommending the approval of ...
Nasdaq4d
Biogen Stock Down on Regulatory Update in the EU for Alzheimer's Drug
Biogen BIIB and Japan-based partner, Eisai, announced an update regarding the regulatory review of an application seeking the approval of Leqembi (lecanemab) for mild cognitive impairment due to ...
pharmaphorum2d
EMA experts will look again at Leqembi's safety data
It seems Eisai and Biogen have another hurdle to jump over in their bid to get EU approval for their Alzheimer's disease therapy Leqembi. In the latest development, the European Commission has ...
Why Are Analysts Bullish on Biogen Inc. (BIIB) Now?
We recently compiled a list of the 12 Best S&P 500 Stocks to Invest in According to Analysts. In this article, we are going ...
pharmaphorum4d
In shock move, EU panel rejects Alzheimer's drug Leqembi
The EMA's human medicines committee has recommended against approval of Eisai and Biogen's Alzheimer's disease therapy Leqembi, after regulators in the US, China, and Japan gave a green light to ...