The FDA investigated the death of a boy in Brazil on Elevidys and concluded it was unrelated to the treatment.

NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended regulators approve Servier's IDH1/2 inhibitor Voranigo (vorasidenib) as a treatment for ...

Trontinemab is a formulation of Roche's failed gantenerumab but now paired with the company's Brainshuttle technology to ...

The Medicines and Healthcare Products Regulatory Agency said it will closely track adverse events associated with the treatment.

The therapies, which are just starting to enter clinical trials, will need to prove clear clinical and quality-of-life ...

Sarepta maintains it reported the incident to the FDA in June, and the boy's doctor had deemed his death was unrelated to treatment.

Despite regulatory setbacks, the petitioners believe that survival and other data they've collected themselves are worth ...

The trial will test several treatment approaches in the maintenance setting for extensive stage small cell lung cancer.

The firm will test gedatolisib as a first-line treatment in patients with HR-positive, HER2-negative advanced breast cancer who are endocrine therapy resistant.

The agency weighed safety data and a new dosing regimen to recommend approval of the treatment for early Alzheimer's disease in certain patients.

Elevidys, which is also facing regulatory hurdles in the US, was developed by Sarepta Therapeutics but is sold by Roche outside of the US.

As first-line treatments in metastatic HER2-positive breast cancer evolve, the firm expects its HER2 targeted therapies to remain integral to growth.