Noting a flurry of recent commentaries in peer-review journals, our February Science Matters column in START-UP ( link here , free access...

With what seemed to be stellar results from the ARISTOTLE trial, showing the first superiority over warfarin on bleeding and mortality f...

Was FOTF the only one to notice that anti-obesity drug maker Vivus aced its FDA advisory committee review on Feb. 22, one day...

On its face, FDA Commissioner Margaret Hamburg’s decision to rescind Avastin ’s breast cancer claim is a clear (though likely not unexpec...

FDA is holding more advisory committees than ever and it’s hard for some not to get lost in the mix. Take the May 19 Endocrinologic ...

Industry is looking for a PDUFA, but could end up with a FDAAA as it searches for an acronym for the biosimilar user fee to join the lexicon...

On the eve of FDA’s Antiviral Drugs Advisory Committee reviews of the first protease inhibitors for hepatitis C, the drugs’ sponsors – Merck...

The first two new therapies cleared by FDA in 2011 feel like hail from a bygone era: a serotonin inhibitor antidepressant and an angiotensin...

Josh Sharfstein's departure back to the friendly Democratic climes of Maryland left HHS management and FDA Commissioner Margaret Hamburg...

The news that FDA Deputy Commissioner Joshua Sharfstein is leaving the agency broke late yesterday, via a tweet by CQ HealthBeat . If you ar...

There was more bad news on Dec. 27 for those developing anti-nerve growth factor (NGF) drugs: U.S regulators put Regeneron's candidate R...

The three obesity drugs—Vivus’ Qnexa, Arena’s Lorqess, and Orexigen’s Contrave—pending at FDA haven’t suffered from a lack of buzz in the in...

There's lots of buzz right now about the potential for FDA to seek jail time for executives involved in quality control problems. This p...

There was some disharmony at Jazz Pharmaceuticals’ FDA panel review of its drug Rekinla for fibromyalgia. FDA’s Arthritis Drugs Advisory Co...

You can be forgiven for skipping yesterday's Cardiovascular and Renal Drugs Advisory Committee. After an incredible series of important ...

FDA just wrapped up a two day public meeting to review the implementation of its Risk Evaluation & Mitigation Strategy authorities. The ...