Aldeyra Therapeutics, Inc.

Despite a second complete response letter from the US Food and Drug Administration to its new drug application for reproxalap in dry eye disease, Aldeyra expects to refile for approval during the midd

Despite the ongoing upheaval across the agency, the US Food and Drug Administration maintained its typical reliability when it came to meeting user fee goal dates in the first quarter of 2025, the Pi

“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