It's no secret: FDA review managers would like to make "complete response" letters public. We've heard that directly from ...

Michael Gilman is the CEO of Stromedix , a Cambridge, MA biotech developing novel drugs to treat fibrotic organ failure. You can follow him ...

InterMune’s roller coaster ride with the idiopathic pulmonary fibrosis therapy pirfenidone took a steep dive back down when FDA issued a “co...

That wacky Pulmonary-Allergy Drugs Advisory Committee is at it again! Last month, we noted the remarkable outcome of the review of Intermun...

Two wrongs may not make a right, but when it came to Pulmonary-Allergy Drugs Advisory Committee member Les Hendeles' views on the approv...