Pharmaceutical Technology on MSN

Biogen’s salanersen gains FDA breakthrough therapy designation for SMA

The FDA's decision follows data from a Phase Ib study on salanersen.
Zacks Investment Research on MSN

BIIB's next-gen SMA therapy Salanersen wins FDA's breakthrough tag

Biogen BIIB recently announced that the FDA has granted Breakthrough Therapy designation to Salanersen, an investigational ...

Should Biogen’s (BIIB) New SMA Breakthrough and Lupus Data Prompt a Fresh Look From Investors?

In early June 2026, Biogen reported that the FDA granted Breakthrough Therapy Designation to its investigational SMA treatment salanersen, while also, alongside UCB, presenting additional positive ...
Yahoo

Breakthrough gene therapy jab reverses hearing loss in weeks

A single jab of a breakthrough gene therapy could reverse hearing loss in people within weeks, according to new research. The cutting-edge therapy improved hearing in children and adults with ...
Nasdaq

Orchestra BioMed Receives FDA Breakthrough Device Designation for Atrioventricular Interval Modulation Therapy to Address Uncontrolled Hypertension

Orchestra BioMed has announced that the FDA has granted Breakthrough Device Designation for its atrioventricular interval modulation (AVIM) therapy, aimed at treating over 7.7 million U.S. patients ...

Breakthrough T1D Canada Calls on Federal Government to Invest in Canada's World-Leading Regenerative Medicine Research in Upcoming Budget

Canada is at risk of missing a critical opportunity to lead the next breakthrough in type 1 diabetes research unless the ...
Monthly Prescribing Reference

Volixibat Granted Breakthrough Therapy Status for PBC-Related Itching

A statistically significant improvement in pruritus was observed in PBC patients treated with volixibat compared with placebo. The Food and Drug Administration (FDA) has granted Breakthrough Therapy ...