Jazz Pharmaceuticals has claimed FDA approval for its HER2-directed bispecific antibody Ziihera as a treatment for biliary ...

US President-Elect Donald Trump is reported to be considering the nomination of Johns Hopkins surgeon and writer Martin Makary to lead the FDA after he takes office in January. The rumour was ...

The patient affected by a serious adverse event in Neurogene's clinical trial of Rett syndrome gene therapy has now died, but that won't cause the study to be halted. The FDA has allowed the company ...

Elon Musk's brain-computer interface (BCI) company Neuralink has been given the green light to test its device in tetraplegic patients in Canada – the first international trial of the technology. The ...

AstraZeneca's anticoagulant reversal agent Andexxa was given an accelerated approval by the FDA in 2018, but the company's plan to get that upgraded to a full approval is facing some pushback. At an ...