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The FDA said Wednesday that its Center for Drug Evaluation and Research and the Office of Prescription Drug Promotion issued 47 warning letters last year, compared with 52 in 2014. Read More
An obesity candidate linked to patient deaths during a clinical trial last year may have a potential path forward after its sponsor revealed that it met its co-primary endpoints in a Phase 3 study. Read More
The FDA’s chief watchdog for drug promotion — the Office of Prescription Drug Promotion — issued its first untitled letter of the year, blasting Hospira for running an online video that omitted multiple required disclosures. Read More
Boehringer-Ingelheim has to hand over settlement papers to the FTC after the U.S. Supreme Court rejected the company’s assertion that the documents are protected communications. Read More
Roche says it is cooperating with inquiries from the Indian states of Gujarat and Telangana, where sales of its cancer drug Avastin were halted after 15 patients experienced pain and swelling in their eyes. Read More