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
Don’t expect the US government’s war on drug pricing to go away any time soon – for once president Trump and his rivals, the Democrat party, agree on something, and both have had some stron
Experts have said the ongoing government shutdown may already have delayed approval and launch of new drugs, as the FDA’s spare cash reserves dwindle with every day that the impasse continu
The future of Sanofi and Lexicon’s oral diabetes drug Zynquista hangs in the balance after an FDA advisory committee was split on whether the drug would benefit patients.
A pharma company’s core mission is to improve patient outcomes. This hinges on effectively influencing HCP clinical behaviour and driving disease education.