Stealth BioTherapeutics Inc.

“Pipeline in a pill”-style drug development will be on display in April, when more than half of the user fee goal dates are for new indications on sometimes sprawling labels, as well as one novel biol

While the FDA is facing a disrupted and uncharted future, drug development offers a few certainties, including that oncology and neuroscience still dominate the novel agents seeking approval. But the

This year has posed substantial challenges for global markets: a prolonged period of high interest rates, ongoing geopolitical instability, democratic uncertainty, and an unprecedented number of natio

The FDA’s ability to exercise regulatory flexibility is not a suitable alternative to a new legislative pathway for rare disease drug developers to meet the Food, Drug, and Cosmetic Act’s “substanti