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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
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
The FDA has approved Auxilium Pharmaceuticals’ Xiaflex biologic injection for Peyronie’s disease, a deformity of the penis caused by a lump of plaque that results in a curvature of at least 30 degrees. Read More