Constant leadership changes and erratic decision-making have left the biopharmaceutical industry feeling its chief regulator ...

The FDA on Thursday promised to start posting its drug rejection letters shortly after they're issued to the pharmaceutical companies sponsoring the products. The agency also published 89 of the ...

Every parent believes that feeding their child something as simple as lettuce is safe. We didn’t think twice about it. We shouldn’t have to. But for my family – and too many others – that assumption ...

Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning morning. Today, we learn the FDA is committing to CRL transparency, ...