INDICATION LEQEMBI ® [ (lecanemab-irmb) 100 mg/mL injection for intravenous use] is indicated for the treatment of Alzheimer’s disease (AD). Treatment with LEQEMBI should be initiated in patients with ...

As users continue to leave X (formerly Twitter) en masse, many in favor of the newer Bluesky platform, the European Medicines ...

An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines Agency (EMA) considerate it as an alternative than the current lower ...

CAMBRIDGE, Mass. - Biogen Inc. (NASDAQ:BIIB), a $20.8 billion biotechnology company with a robust 75.6% gross profit margin, ...

We are pleased to announce that our applications for the higher dose regimen of nusinersen are now under review in the US and Europe,” said Stephanie Fradette, Pharm.D., Head of the Neuromuscular ...

Biogen said the U.S. Food and Drug Administration has accepted its supplemental new-drug application, while the European Medicines Agency has validated its application, which confirms that the ...

Pharma: Launch of Shortages Monitoring Platform, several Changes re Clinical Trial Management in EU Countries; Devices: Resolution on the need ...

"The bottom line is that withdrawing from the WHO makes Americans and the world less safe," says Dr. Tom Frieden, president ...

Acadia Pharmaceuticals has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for ...

Acadia Pharmaceuticals (ACAD) announced that the company has submitted a marketing authorization application to the European Medicines Agency ...

Credit: Jo Panuwat D/Shutterstock. Actuate Therapeutics has gained orphan medicinal product designation (OMPD) from the European Medicines Agency (EMA) for elraglusib to treat pancreatic ductal ...

The European Medicines Agency (EMA) announced that it will review 2 Danish studies which indicate there may be a link between semaglutide injection drug Ozempic (Novo Nordisk) and non-arteritic ...