Capricor Therapeutics, Inc.

The regenerative medicine sector continues to seek increased contact with the US Food and Drug Administration, even as the architects of the Center for Biologics Evaluation and Research review structu

The US Food and Drug Administration heard mixed messages about what, if any, findings from two opioid analgesic product postmarketing studies should be included in labeling or communicated to patients

One-third of all the regenerative medicine advanced therapy (RMAT) designations granted by the US Food and Drug Administration’s Center for Biologics Evaluation and Research were awarded in fiscal yea

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