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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
Amgen and Sanofi are the latest companies to climb on the pay-for-performance bandwagon after reaching agreements with insurer Cigna for their respective cholesterol drugs, Repatha and Praluent. Read More
Two more compounding pharmacies are in the FDA’s crosshairs, with one faulted for failing to maintain proper sterility while the other was accused of compounding without valid prescriptions. Read More
Despite the FDA approving more than 99 percent of expanded access requests and offering emergency access authorization, a Senate committee chairman introduced legislation Tuesday that prohibits the FDA from interfering in the prescribing of investigational drugs to terminally ill patients. Read More
French authorities want to ban marketing applications from an Indian manufacturing site after an inspection turned up a whopping 58 GMP violations. Read More