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Shire v. Blackburn: Drawing the Line Between FDA Drug Labeling Regulations and State Law on Product Liability

On June 2, 2023, drug manufacturer Shire US Inc. and related entity Shire LLC (collectively, “Shire”) asked the Supreme Court to review an Eleventh Circuit ruling involving the interplay between state tort law and FDA...more

Supreme Court Issues Stay in Mifepristone Case, Preserving Status Quo for Now

On April 21, 2023, the Supreme Court granted a stay in Alliance for Hippocratic Medicine v. FDA, a case concerning the Food and Drug Administration’s approval of and access to the widely used abortion pill mifepristone. The...more

Aralez’s YOSPRALA wins FDA approval

On September 15, 2016, the U.S. Food and Drug Administration approved once-daily YOSPRALA™, a tablet that combines the anti-platelet agent, aspirin, with the anti-acid drug, omeprazole for decreasing the risk of...more

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