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An FDA advisory committee recommended the approval of Merck’s bezlotoxumab to prevent Clostridium difficile infection recurrence in patients 18 and older. Read More
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