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The European Union wants to expand ongoing trade talks between the U.S. and EU to address regulatory harmonization on drug approval requirements, guidelines and GMP compliance. Read More
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