Biogen’s applications for the higher dose regimen of SMA drug Spinraza are now under review in the US and Europe.

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, ...

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 ...

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 ...

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

A safety committee will review all evidence from trials and studies to shed more light on the potential risk of NAION.

Rising diagnoses of certain cancers in people under 50 predate the rollout of COVID-19 vaccines by decades, undermining ...

EQS-News: Formycon AG / Key word (s): Regulatory Approval Formycon receives EU approval for FYB203 (aflibercept), a biosimilar to Eylea®, under the brand names AHZANTIVE® and Baiama® 20.01.2025 / ...

“We are certainly prepared for any scenarios that might come to the table,” Director General of the European Space Agency (ESA) Josef Aschbacher said. “ESA and Europe will be ready to adjust, to find ...

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 ...

Medicines must now have ... and Healthcare products Regulatory Agency (MHRA). That was the situation before Boris Johnson’s deal with the European Union for special trading arrangements ...