![]() | Investors, patients and activists, no doubt, hope they won't have to put out a mayday distress call, but as Dendrama's fate would have it, the company announced today that the Food and Drug Administration has assigned May Day as its decision day for the prostate cancer treatment Provenge. » Read more |
![]() | It doesn't always happen, but there is a common to-and-fro, push-and-pull, back-and-forth or whatever you want to call it between reporters and corporate PR folks. I don't particularly like that part of my job, but sometimes it just comes with the territory. I've got my job to do and they've got theirs. I get it. » Read more |
![]() | Today starts a two-day FDA public hearing in Washington, DC on biopharma and social media. I decided not to go because talking heads in a meeting room just don't make for good TV. And this is just the first step in what is no doubt going to be a very long, involved policy-making process. But as it turns out, it looks like it might have been futile for me to try to attend anyway. » Read more |
![]() | When I went to the FDA's Web site today I was surprised to see on the homepage a link to a letter written by Commissioner Dr. Peggy Hamburg. It's addressed to "Dear Healthcare Professional" aka a "Dear Doctor letter." That's a common type of communication from the agency and/or companies to the medical community, usually when they've got bad news to pass along about a drug or device. It's pretty rare for the commish to write one. » Read more |
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