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The FDA expects companies to build up “robust IT systems and internal processes” to make sure they are tracking and reporting adverse events. Read More
The EMA’s Committee for Medicinal Products for Human Use (CHMP) flagged 13 medicines for approval at its April meeting, including two orphan medications and a biosimilar. Read More
Washington state regulators have awarded AbbVie an exclusive contract to help the state rid itself of Hepatitis C within the next decade—the nation’s second state to adopt a subscription payment model. Read More
Drugmakers and regulators urgently need to create a pipeline of drugs to treat the growing threat of antibiotic-resistant diseases, the World Health Organization says in a new report issued Monday. Read More
Eli Lilly on Friday pulled its sarcoma treatment Lartruvo just ahead of European regulators announcing that the antibody had failed to prove its effectiveness in a pivotal clinical trial. Read More