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Regulatory

A total of 29 posts are filed under Regulatory
What the FDA’s New Framework Means for Regenerative Therapies
Earlier this month, the U.S. Food and Drug Administration announced a comprehensive policy framework for the development and oversight of… Continue Reading
FDA Orphan Drug Designation in November 2017
The following is a list of U.S. Food and Drug Administration orphan drug designation issued in November 2017… Continue Reading
Trump Taps Former Drug Industry Exec to Head HHS
Daniel S. Levine President Donald Trump said he would nominate Alex Azar, an attorney and former drug industry executive who served in the… Continue Reading
Health Canada Scraps Plans for Orphan Drug Framework
Health Canada has derailed a long-fought effort to establish a framework for orphan drugs. Last month the agency, without warning, removed… Continue Reading
FDA Expands Approval of Roche’s Zelboraf as First Treatment Rare Blood Cancer
Rare Daily Staff The U.S. Food and Drug Administration said it expanded the approval of Roche’s  Zelboraf to include the treatment of… Continue Reading
Ionis Submits Application to FDA to Market Antisense Drug for hATTR
Rare Daily Staff Ionis Pharmaceuticals said it submitted a new drug application to the U.S. Food and Drug Administration for inotersen, an… Continue Reading
FDA Grants Rare Pediatric Disease Designation to ArQule’s Miransertib for Proteus Syndrome
Rare Daily Staff The U.S. Food and Drug Administration granted ArQule Rare Pediatric Disease Designation for its experimental therapy… Continue Reading
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