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In stark contrast to comments from generic industry trade groups, a patient advocacy organization is calling for including more information in biosimilar product labeling. Read More
Two FDA advisory committees backed the approval of Pfizer’s opioid Troxyca for severe pain management when alternative treatments are inadequate with abuse-deterrent labeling for nasal and intravenous routes. Read More
British authorities have warned Reckitt Benckiser that it may have to submit all advertising for vetting if it makes another false efficacy claim for its laxative Senokot. Read More
Despite the FDA extending the comment period for its recommendations on biosimilar labeling, several industry groups have still made public their concerns about the draft guidance. Read More
To drive the development of advanced therapies, industry is asking the European Medicines Agency to provide further guidance, harmonize EU regulations and exercise flexibility. Read More