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The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended ten medicines for approval, including two orphan medicines and a new treatment for multiple sclerosis. Read More
The FDA is working to prevent manufacturers of branded high-risk drugs from stalling an application for approval of a generic competitor via manipulation of a requirement to share safety programs, Commissioner Scott Gottlieb said. Read More
Responding to changes introduced by the GDUFA II program, the FDA revised its draft guidance on sponsor pre-submissions of facility information used to assess the need for manufacturing site inspections for priority applications. Read More
FDA advisory committee members recommended approval for some versions of Braeburn’s modified-release reformulation of buprenorphine but balked at endorsing higher dosages of the medication, which is indicated for weekly or monthly treatment of opioid abuse. Read More
The IV drug was approved for use in combination with other antiemetics to treat adults experiencing delayed nausea and vomiting after chemotherapy. Read More