regulatory

News

A court has ordered the FDA to revisit a decision to turn down a drug for jet lag developed by Vanda, potentially setting a crucial legal precedent.

News

A leaked version of the Make America Healthy Again programme for the Trump administration has plenty for the pharma industry to stew over.

Digital

Remember when I said that patients are coming to doctors with formed opinions – if they come to physicians at all?

News

An oral alternative to injectable treatment for uncomplicated gonorrhoea could be on the way in the US, as FDA starts review of GSK's gepotidacin.

News

The FDA has added a warning label to bluebird bio's Skysona, after launching a probe into cases of blood cancer linked to the gene therapy.

News

In a new spin on the concept of the FDA's 'revolving door', Vinay Prasad is back as head of CBER, just over a week after leaving the role.