The COVID-19 pandemic forced investigators conducting clinical trials to use decentralized elements, such as telehealth, to ...
H.C. Wainwright reaffirmed a Buy rating on Cartesian Therapeutics shares, maintaining the $45.00 price target, representing a ...
Cartesian Therapeutics has secured an agreement from the US Food and Drug Administration (FDA) under the Special Protocol ...
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., ...
Cartesian Therapeutics (RNAC) announced that it has received written agreement from the U.S. Food and Drug Administration, FDA, under the ...
The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: ...
Outlook Therapeutics plans to resubmit ONS-5010 for FDA approval in 2025 following NORSE EIGHT trial results in wet AMD patients.
ONS-5010 did not meet the pre-specified non-inferiority endpoint at week 8 outlined in the special protocol assessment (SPA) with the U.S. Food and Drug Administration (FDA). However, BCVA data ...
WASHINGTON — Special counsel Jack Smith said his team "stood up for the rule of law" as it investigated President-elect Donald Trump's efforts to overturn the results of the 2020 election ...
Firefly Neuroscience, Inc. has announced progress in research using its FDA-cleared Brain Network ... facets of human brain aging. BNA™ data assessment, for example, is capable of finding ...