The FDA has approved the sBLA for once every 4 weeks lecanemab-irmb (Leqembi®) intravenous maintenance dosing.

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

In the latest development, the European Commission has asked the EMA's human medicines committee, the CHMP, to take a look at ...

With thousands of press releases published each week, it can be difficult to keep up with everything on . To help healthcare ...

FDA approval of LEQEMBI ® maintenance dosing and a new CVS Health app. NEW YORK, Jan. 31, 2025 /PRNewswire/ -- With thousands of press releases published each week, it can be difficult to keep up ...

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 ...

Leqembi is the result of a long-standing collaboration ... A supplemental Biologics License Application (sBLA) for less frequent intravenous maintenance dosing was approved by the U.S. Food ...

BioArctic’s partner Eisai announces update on regulatory review of lecanemab to treat early Alzheimer’s disease in EU: Stockholm Monday, February 3, 2025, 13:00 Hrs [IST] BioA ...

Viehbacher, “Biogen”) announced today an update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab as treatment for early AD (mild cognitive impairment due to ...

2025 The U.S. Food and Drug Administration has approved monthly maintenance dosing for Japan's Eisai and partner Biogen's Alzheimer's drug Leqembi, the companies said on Monday. US FDA OKs monthly ...