Europe to review safety data for Eisai-Biogen Alzheimer's drug
The European Commission has requested its medicines regulator to consider safety information on Eisai and Biogen's ...
US FDA OKs monthly maintenance dosing for Eisai/Biogen's Alzheimer's drug
The U.S. Food and Drug Administration has approved monthly maintenance dosing for Japan's Eisai and partner Biogen's ...
PMLiVE5d
Biogen/Eisai’s Alzheimer’s drug approved by FDA for monthly maintenance dosing
Biogen and Eisai’s Alzheimer’s disease (AD) drug Leqembi (lecanemab-irmb) has been approved by the US Food and Drug ...
Biogen, Eisai: EC Asks CHMP to Take Another Look at Leqembi
Biogen and Eisai said they believe that EC's requests can be addressed with existing information, and that no new safety signals have been identified for Leqembi. The U.S. Food and Drug Administration ...
The Pharma Letter5d
Eisai and Biogen gain FDA approval for monthly Leqembi
Eisai and Biogen have secured US Food and Drug Administration approval for a once-monthly intravenous maintenance dosing ...
BioSpace9d
Biogen Trims Research Workforce, Higher-Dose SMA Drug Accepted for Regulatory Review
In a good-news-bad-news week for Biogen, the company will cut an undisclosed number of employees, just as a higher dose of ...
Zacks.com on MSN8d
FDA & EMA Accept Biogen's Filings for Higher Dose SMA Drug
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.
FiercePharma1d
Merck vaccine, Daiichi ADC win approval recommendations in busy week at EU's drug regulator
Several medicines are poised to reach new heights after winning key endorsements from European drug regulators. | Among those ...
Sage rejects Biogen’s buyout offer, but says it's open to deals
Sage Therapeutics has rejected the unsolicited acquisition offer it received earlier this month from longtime partner Biogen ...
FDA approves Eisai, Biogen’s sBLA for lecanemab-irmb IV dosing
Eisai (ESAIY) and Biogen (BIIB) announced that the U.S. Food and Drug Administration, FDA, has approved the Supplemental Biologics License ...
Kyodo News on MSN5d
US regulator OKs Eisai-Biogen Alzheimer's drug's continuous dosing
Japanese pharmaceutical company Eisai Co. and U.S. firm Biogen Inc. said Monday that a jointly developed Alzheimer's drug has ...