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96,999 Results for "cmc biologics".
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Press Releases
Solvias to Speak at Festival of Biologics 2025 on Building Robust CMC Assays for Biologic Therapies
April 23, 2025
·
2 min read
Press Releases
Lexeo Therapeutics to Present New CMC Data at the 28th American Society of Gene & Cell Therapy (ASGCT) Annual Meeting
May 1, 2025
·
4 min read
Business
Spago Nanomedical Strengthens Management with Head of CMC & Supply
Spago Nanomedical Spago Nanomedical AB announced the appointment of Birgitta Rembratt Svensson as Head of CMC & Supply.
April 16, 2024
·
1 min read
Pharm Country
Tonix Pharmaceuticals Announces Positive Pre-NDA CMC Meeting with FDA for Tonmya™ for the Management of Fibromyalgia
Tonix Pharmaceuticals Holding Corp. today announced receipt of the formal minutes from a recent pre-New Drug Application (NDA) Type-B Chemistry, Manufacturing, and Controls (CMC) meeting with the U.S. Food and Drug Administration (FDA) for Tonmya™ for the management of fibromyalgia.
June 20, 2024
·
7 min read
Drug Development
BrainStorm Cell Therapeutics Reaches Alignment with FDA on CMC Aspects of Phase 3b NurOwn® Clinical Trial
BrainStorm Cell Therapeutics Inc. ment with the U.S. Food and Drug Administration (FDA) on the Chemistry, Manufacturing, and Controls (CMC) aspects of Brainstorm’s Phase 3b clinical trial for NurOwn.
June 26, 2024
·
4 min read
Press Releases
IMUNON Announces Positive CMC Meeting with FDA for IMNN-001 in Treatment of Advanced Ovarian Cancer
December 20, 2024
·
6 min read
Regulatory
FDA Delays Decision on Merus Bispecific Antibody to Review CMC Information
Despite the PDUFA date being extended by three months for Merus’ zenocutuzumab, Truist Securities analyst Asthika Goonewardene in a Tuesday note to investors said the delay is not a cause for concern with an approval expected.
November 5, 2024
·
2 min read
·
Tristan Manalac
Press Releases
CMC Pharma Extends Shelf-life of Medical Countermeasure, Receives FDA Approval
November 13, 2024
·
1 min read
Press Releases
Biopharmaceutical Research Company (BRC) Announces Development and Regulatory Milestone Following Successful Type C CMC Meeting with FDA, Advancing Clinical Development of Multiple Therapeutic Candidates
January 30, 2025
·
4 min read
Press Releases
Longeveron® Appoints Devin Blass as Chief Technology Officer and SVP of Chemistry, Manufacturing and Controls (CMC)
November 11, 2024
·
7 min read
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