Tag Archives: PDUFA

Big Wins, a Cliff, a Race and a Red Face: A 2012 Recap

Now that 2012 is drawing to a close, it’s once again time to take a look back at a year that saw some big hits and misses for the biotech industry – and there were plenty of both. The hits…


The Star-Struck FTC

The FTC seems to have come down with a bad case of star envy. Not content with its supporting role as implementer of laws duly passed by Congress, the agency is intent on rewriting the script, casting itself as headliner…


It’s About the Patient

An FDA advisory committee this week gave a half-hearted vote of approval – 9-8, with two abstentions – for Alexza Pharmaceuticals Inc.’s Adasuve (Staccato loxapine). But the vote was conditioned on limiting the inhaled antipsychotic to one dose per day…