Biogen filed aducanumab with the FDA in July last year and the regulator granted a faster six-month Priority Review in August lasty year. With the extension the FDA is now due to make a decision ...

For Biogen, an expensive gamble has paid off, as even with accelerated approval the company stands to make billions of dollars from aducanumab, given it estimates there are around 1.5 million ...

Biogen said on Wednesday it would discontinue developing and commercializing Aduhelm (aducanumab-avwa) 100 mg/mL injection for intravenous use and terminate the ENVISION clinical study.

The Sarepta and Biogen therapies mentioned are, respectively, Exondys 51 (eteplirsen) and Aduhelm (aducanumab). They are used for Duchenne muscular dystrophy and Alzheimer's disease. The FDA's ...

In 2023, the FDA withdrew its approval of HPC after a years-long battle. In 2024, Biogen stopped selling aducanumab. The FDA's accelerated approval program was designed to speed the development ...

Amid the uproar over the firing of 18 inspectors general, a report offering a coda to the aducanumab approval episode has ...

Jan 10 (Reuters) - Drugmaker Biogen (BIIB.O), opens new tab will buy all outstanding shares of Sage Therapeutics (SAGE.O), opens new tab that it does not already own for $7.22 apiece, a filing ...

Biogen has offered to purchase Sage’s outstanding shares for $7.22 each, according to a securities filing from Friday. The proposal values Sage at around $442 million. A yearslong partner of ...