After falling behind in the race for new diabetes treatments, partners Bristol-Myers Squibb and AstraZeneca Thursday got a boost in the form of a nearly unanimous recommendation from FDA advisors for their drug Forxiga. Read More

A new House bill aims to build on the success of the Generating Antibiotics Now (GAIN) Act by allowing drugmakers to submit less data for antibiotics and antifungals that affect limited patient populations. Read More

A bipartisan federal budget deal reached Tuesday removes the threat of sequestration hanging over fiscal 2014 and 2015 FDA user fees, and would ensure they aren’t locked away along with some of last year’s payments. Read More

The FDA’s new breakthrough therapy designation has exploded in popularity, the agency says. Read More

Still smarting from a 2012 parliamentary report lampooning India’s oversight of new drugs, the Ministry of Health is calling for accreditation of clinical trial sites and tougher regulation of clinical research. Read More

Lawmakers want the FDA to explain how hackers broke in to the CBER online submission system to steal personal user information and what the FDA has done to prevent a recurrence. Read More

HHS has approved the overhaul of the FDA's Office of Generic Drugs (OGD), allowing the agency to move most of its functions relating to generic drugs under one roof. Read More