FDA

News

The FDA has laid out a framework to use 'prior knowledge' on manufacturing, non-clinical, and clinical data to support cell and gene therapy filings.

News

The turmoil at the FDA continues with the news that Tracy Beth Høeg has been fired as acting head of CDER, to be replaced by Michael Davis.

News

According to multiple press reports citing anonymous insider sources, Dr Marty Makary has resigned after a year at the head of the FDA.

News

Marty Makary's position as FDA Commissioner is said to be in jeopardy, raising the threat of further chaos at the agency if he is ousted.

Oncology

Five years after its launch, the FDA’s Project Optimus remained a key theme in discussions at AACR 2026.

News

The FDA has published a plan to allow data from clinical trials to be reported to the agency as they occur in real time.