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.

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

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