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The approval was based on two clinical studies with statistically significant reductions in treated bleeds compared to previous treatments with a bypassing agent. Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended marketing authorizations for 92 drugs and biologics in 2017, an increase from 81 in 2016 but down from 93 in the previous year. Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended seven new products for European Commission approval, including one biosimilar and two orphan medicines, one being an advanced cell therapy. Read More
The FDA denied a request from Allergan to reject any ANDAs referencing Restasis unless the applicant proves bioequivalence through clinical endpoints. Read More