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CMC
Pharma
Biogen undeterred after FDA snub for high-dose Spinraza in SMA
Despite possessing solid data on high-dose Sprinraza in spinal muscular atrophy, Biogen must revise its application if it hopes to secure an approval.
Fraiser Kansteiner
Sep 24, 2025 9:51am
FDA debuts new program to ease US manufacturing plant setup
Aug 7, 2025 3:16pm
Savara's lung disease asset hit with FDA refuse-to-file letter
May 27, 2025 10:35am
Manufacturing issues force PolarityTE to halt skin repair IND
Aug 24, 2021 11:06am
FDA puts Altimmune's intranasal COVID-19 vaccine trial on hold
Jan 5, 2021 8:32am
Novavax delays U.S. trial amid FDA manufacturing 'questions'
Nov 30, 2020 10:15am
