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An FDA advisory committee recommended approval of Sanofi’s combination candidate for Type 2 diabetes Wednesday, making it the second such product backed by the committee in the last 24 hours. Read More
An Indian court is ordering Pfizer to honor an earlier promise to dump large quantities of its steroid Medrol prior to the drug’s expiration date. Read More
The FDA is proposing a surveillance plan for Merck’s Gardasil 9 to screen for four potential adverse risks associated with human papillomavirus vaccines. Read More
France is tightening restrictions on early-phase clinical trials in the wake of one study that left one patient brain-dead and hospitalized five others. Read More
Cynthia Schnedar, director of CDER’s Office of Compliance, stepped down from her role on March 18 to take an unspecified private sector job, according to an email from CDER Director Janet Woodcock. Tom Cosgrove, who until recently served as director of the OC’s Office of Manufacturing Quality, assumed her position on April 4. Read More
Lunada Biomedical is barred from claiming that a dietary supplement can address perimenopausal and menopausal symptoms under a settlement agreement with the Federal Trade Commission. Read More