Janssen’s potential depression treatment made from esketamine – a version of the substance notoriously used illegally as a party drug – is to be reviewed by advisers to the FDA at a crunch
Daiichi Sankyo has been given a priority review from the FDA for pexidartinib, which is vying to become the first systemic drug therapy for rare cancer tenosynovial giant cell tumour (TGCT).
The FDA has published new premarket guidance on efficient development and review of combination products, which often combine drugs or biologic medicines with a device. In a statem
An adviser to the FDA has said that the organisation is at war with itself over its policy towards opioid drugs, accusing the organisation of failing to learn lessons from the addiction cri