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

The FDA's decision follows data from a Phase Ib study on salanersen.

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 ...

Daraxonrasib belongs to a new class of medicines known as RAS(ON) inhibitors. The drug targets the active form of RAS ...

Salanersen, which is designed for once-yearly dosing, is a potential successor to Biogen's blockbuster SMA drug Spinraza, which generated worldwide sales of nearly $1.55 billion last year and requires ...

A breakthrough targeted therapy, mirvetuximab soravtansine, is offering new hope to women with hard-to-treat ovarian cancer.

Nipocalimab 15mg/kg improved ClinESSDAI score compared with placebo (treatment difference -2.65; [90% CI, -4.03, -1.28]; P =.002). The Food and Drug Administration (FDA) has granted Breakthrough ...

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 ...

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 ...

At Breakthrough Therapy and Resources, we provide clinical support for individuals experiencing distress due to various life experiences. Utilizing a range of therapeutic interventions, we offer ...