regulatory

News

The WHO has recommended Gilead's twice-yearly HIV PrEP drug lenacapavir, calling it 'transformational', but there are concerns about patient access.

News

The FDA says publishing complete response letters for medicines is an act of "radical transparency," but it is not as revolutionary as it seems.

News

Nine adverts for weight-loss services have been banned by the Advertising Standards Authority in the UK for promoting prescription-only drugs.

News

Novo Nordisk has moved quickly to file for approval of a higher-dose version of obesity drug Wegovy as it fends off stiff competition from Eli Lilly.

News

J&J is hoping the AMPLITUDE study results will make Akeega the first drug in the PARP inhibitor class for castration-sensitive prostate cancer.

Market Access

The MHRA, will be running five pilot dialogues as part of its first year exploring a real-world evidence scientific dialogue programme.