WASHINGTON – The reauthorization of PDUFA could lead to a change in mission for the FDA that would require the agency to couple economic growth and job creation with its public health duties.

Five Prime Therapeutics Inc. added another notch to its growing list of biologics-development relationships with big pharma players, signing on with GlaxoSmithKline plc for their second partnership.

When is a sales rep not a sales rep? That's the question the Supreme Court faced Monday as it heard arguments in a case that could change the 70-year-old paradigm of pharma sales reps.

When patent protection expired in November for Pfizer Inc.'s Lipitor (atorvastatin), many mourned its passing as the end of the golden age of mega blockbusters.

WASHINGTON – The SEC has its work cut out for it in implementing the new Jumpstart Our Business Startups (JOBS) Act. But before it rolls up its sleeves, it's turning to the public for guidance.

On its way to the public trough, ArQule Inc. decided to go for a bigger portion, opting to increase its underwritten offering to 7.15 million shares priced at $7.30 per share.

Big pharma is refusing to go quietly into the night as its biggest blockbusters fall off the patent cliff, endangering more than half of some drugmakers' brand portfolios.

WASHINGTON – The Supreme Court is being asked to curb a growing cottage industry of shareholder lawsuits by raising the bar for class actions alleging companies have frauded the market.

WASINGTON – Despite warnings against weighing down the PDUFA and other user fee agreements negotiated between the FDA and industry, Congress is piling on the calories with favorite menu items ranging from drug shortage notification to social media guidance.

WASHINGTON – With more riding on the reauthorization of PDUFA than ever before, a Senate committee is pushing through a package of user fees with a warning against bogging it down with costly and controversial measures.