pharmaphorum14h
EMA experts will look again at Leqembi's safety data
In the latest development, the European Commission has asked the EMA's human medicines committee, the CHMP, to take a look at ...
Weekly Roundup: 12 Health Press Releases You Need to See
With thousands of press releases published each week, it can be difficult to keep up with everything on . To help healthcare ...
Kauppalehti17h
Update on Regulatory Review of Lecanemab for Early Alzheimer’s Disease in the European Union
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 ...
Medscape13h
EMA to Review New Safety Data on Alzheimer’s Drug Leqembi
The reassessment of Leqembi’s safety data follows the agency’s previous recommendation of the drug for use in the EU.
Update on regulatory review of lecanemab for treatment of early Alzheimer's disease in the European Union
BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that the European Commission has asked the Committee ...
Managed Healthcare Executive8h
FDA Approves Journavx as a New Non-Opioid Pain Med for Acute Pain Relief
The FDA recently approved Vertex Pharmaceuticals Incorporated’s Journavx (suzetrigine), a first-in-class non-opioid medication for treating moderate to severe acute pain in adults. Journavx, approved ...
Biogen, Eisai Alzheimer’s drug review delayed in EU
Biogen (NASDAQ:BIIB) and Eisai (OTCPK:ESALF) are expected to face another delay in launching their new Alzheimer's drug, lecanemab, in the EU after the European Commission on Friday asked the region's ...