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The Office of Generic Drugs had a banner year in 2015, seeing more than 700 full and tentative approvals, the agency announced in April in its first-ever report on generics. Read More
FDA regulators are pushing back the clock on orphan drug reviews from 90 days to 120 days in an effort to keep pace with heavier-than-expected workloads. Read More
The UK’s drug pricing watchdog is backing coverage for Human Genome Sciences’ Benlysta as an add-on treatment for systemic lupus erythematosus. Read More
The UK’s drug pricing watchdog seems to have warmed to AbbVie’s Humira, recommending the drug be covered four months after one of its committees proposed rejecting it. Read More