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Complete response letters

Pictured: Illustration of antibodies attacking a nerve cell
Policy
FDA Rejects Viatris, Mapi’s Long-Acting Multiple Sclerosis Injection
With Monday’s FDA rejection of their long-acting glatiramer acetate formulation, Viatris and Mapi Pharma continue the biopharma industry’s recent losing streak in multiple sclerosis.
March 11, 2024
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2 min read
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Tristan Manalac
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PRESS RELEASES
Press Releases
Capricor Therapeutics Responds to FDA Posting of Complete Response Letter (CRL) for Deramiocel
September 10, 2025
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6 min read
Press Releases
Saol Therapeutics Receives Complete Response Letter from FDA for SL1009 (DCA) for the Treatment of Pyruvate Dehydrogenase Complex Deficiency (PDCD)
September 9, 2025
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3 min read
Press Releases
enVVeno Receives Not-Approvable Letter from the FDA for the VenoValve(R)
August 20, 2025
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4 min read
Press Releases
FDA Issues Complete Response Letter for Etripamil for PSVT
March 31, 2025
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5 min read
Press Releases
Lexicon Announces Receipt of Complete Response Letter for Zynquista™ (sotagliflozin)
December 23, 2024
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3 min read
Press Releases
U.S. Food and Drug Administration issues Complete Response Letter for the glepaglutide New Drug Application for the treatment of short bowel syndrome
December 20, 2024
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8 min read
Press Releases
Satsuma Pharmaceuticals and SNBL Resubmits the New Drug Application for STS101 (Dihydroergotamine Nasal Powder) for the Acute Treatment of Migraine With or Without Aura
October 31, 2024
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5 min read
Press Releases
PharmaTher Receives Complete Response Letter from the U.S. Food and Drug Administration for Ketamine Abbreviated New Drug Application
October 24, 2024
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4 min read
Press Releases
Regeneron Provides Update on Biologics License Application for Linvoseltamab
August 21, 2024
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7 min read
Press Releases
Novo Nordisk receives Complete Response Letter in the US for once-weekly basal insulin icodec
July 11, 2024
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2 min read