Leaders from the world of cell and gene therapy shared their personal stories and policy recommendations in an extraordinary ...

The FDA has said it will expand unannounced inspections of overseas manufacturing facilities supplying medicine and other medical products to the US. The aim is to make sure that foreign companies ...

Health and Human Services (HHS) Secretary Robert F Kennedy Jr, who oversees the FDA, has made no secret of his desire to ban prescription drug advertising on television in comments made before his ...

In a surprise post this afternoon, new FDA Commissioner Dr Martin Makary announced a completed pilot at the FDA of a generative AI-based system for speeding up drug review - and plans to roll out ...

Click Therapeutics' digital therapeutic (DTx) CT-132 has been approved by the FDA, becoming the first treatment of its type in the US for preventing attacks in people with episodic migraine.

The FDA has started a priority review of Insmed's brensocatib, which is pitching to become the first approved therapy for chronic lung disease bronchiectasis in the US. The regulator has set a ...

Novo Nordisk has filed another Citizen's Petition with the FDA seeking to block compounding pharmacies in the US from making versions of one of its GLP-1 agonist drugs. The latest attempt focuses ...

Rumours that Donald Trump had chosen Martin Makary as FDA Commissioner have been confirmed ... Trump's Health and Human Services Secretary pick Robert F Kennedy Jr – could end up having major ...

The FDA has published its long-awaited update to guidance to make sure clinical trials more closely reflect the range of patients that might be treated with a new therapy in the real world.

Current first-line therapies like allopurinol and febuxostat can be very effective, but some patients – roughly 1% according to FDA estimates – don’t get the hoped-for benefit, while others ...