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A year after announcing his Precision Medicine Initiative, President Barack Obama has outlined progress on the project, which aims to accelerate personalized medicine. Read More
EMA Recommends Orphan Status for AstraZeneca/Acerta’s Acalabrutinib for Three Indications
True North’s TNT009 Scoops Up Orphan Drug Status for Hemolytic Anemia Read More
A new report pushes states to agree on common standards for traditional compounding operations and recommends a series of best practices for all to follow. Read More
A new analysis of state regulatory controls on compounding operations has found significant variance in their oversight and enforcement of traditional compounding operations. Read More
Organizations conducting clinical trials will no longer have to submit routine GCP compliance reports that have been used to establish inspections with the UK’s Medicines and Healthcare products Regulatory Agency. Read More
French drug giant Sanofi will terminate its licensing agreement with Auvi-Q developer kaléo later this year, returning U.S. and Canadian rights to the epinephrine injection to the company. Read More
Lilly Snags EU Approval for Lung Cancer Drug
Allergan Gains Priority Review for Expanded Avycaz Label
Retrophin Nabs EU Orphan Drug Status for RE-024 Read More
In a case with broad implications for medical patent protection, the U.S. Supreme Court showed little enthusiasm for lowering a strict appellate standard for enhanced damages during oral arguments Tuesday. Read More