BioSpace News Archive

Policy

FDA Grants Priority Review to Genentech’s Risdiplam for Spinal Muscular Atrophy

Filing submission includes 12-month data from pivotal FIREFISH and SUNFISH trials in a broad population of people living with Types 1, 2 or 3 SMA

November 25, 2019
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6 min read
Policy

PTC Therapeutics Announces FDA Grants Priority Review to Risdiplam for the Treatment of Spinal Muscular Atrophy

PTC Therapeutics, Inc. announced that the United States Food and Drug Administration has granted priority review for the New Drug Application for risdiplam for the treatment of spinal muscular atrophy.

November 25, 2019
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6 min read
Policy

Chi-Med Announces Surufatinib Granted FDA Orphan Drug Designation for Pancreatic Neuroendocrine Tumors

Hutchison China MediTech Limited today announces that the U.S. Food and Drug Administration has granted Orphan Drug designation to surufatinib for the treatment of pancreatic neuroendocrine tumors..

November 25, 2019
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8 min read