This SPA agreement marks an important milestone in the development of Descartes-08 for MG, providing critical regulatory clarity and a clear path toward potential approval,” said Carsten Brunn, Ph.D., ...
FREDERICK, Md., Jan. 27, 2025 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering ...
Cartesian Therapeutics has secured an agreement from the US Food and Drug Administration (FDA) under the Special Protocol ...
Cartesian Therapeutics, Inc. announced that it received FDA agreement on the design of its upcoming Phase 3 AURORA trial for Descartes-08, an mRNA cell therapy intended for treating myasthenia ...
The Special Protocol Assessment or SPA agreement confirms that ... Descartes-08 has received Orphan Drug Designation and Regenerative Medicine Advanced Therapy Designation from the FDA for MG ...
NEW YORK, Jan. 22, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of ...