FierceBiotechFierceBioResearcherFierceVaccinesFiercePharma   FierceHealthcare
Syndicate content

NME news from FierceBiotech

News

GSK's Garnier: FDA raised the bar for new drugs

In an interview with the Financial Times, outgoing GSK CEO Jean-Pierre Garnier shares his thought on the new, tougher FDA approval environment. While many drug developers hope the FDA's reticence Read more...

FDA picking up the pace on '08 approvals

Last year's awful record of new drug approvals by the FDA has been followed by a burst of new activity. Pharmalot reports new analysis indicating 29... Read more...

FDA rejections signal tougher developers standards

Faced with back-to-Read more...

Developers: Politics behind slow approval process

Woodcock's defense, though, may seem particularly hard to accept at a slate of big pharma companies which have been able to win European approvals only to run straight into a roadblock at the U.S.... Read more...

2008 NME approvals no better than last year?

In 2007, there was much ado about the slow pace of new molecular entity (NME) approvals. Though over 200 drugs were approved in 2007, only 19 of... Read more...