© 2022 MJH Life Sciences and CGTLive™. All rights reserved.
© 2022 MJH Life Sciences™ and CGTLive™. All rights reserved.
November 12, 2022
BrainStorm received indication from the FDA that it is able to request a Type A meeting to discuss the content of the refusal to file letter.
July 22, 2022
The gene therapy received a positive CHMP opinion in May 2022.
June 16, 2022
The approval came earlier than the recently extended PDUFA date of July 24, 2022.
March 16, 2022
Sarepta also presented updated data from Study 101 of SRP-9001 at MDA 2022.
March 10, 2022
Patients demonstrated a median reduction of 63.5% in CSF NfL levels 6 months after treatment.
December 08, 2021
Autologous adipose stem cell data in a small cohort provides a feasibility for future validation studies.
December 01, 2021
ALSFRS-R and FVC values were stable 3 months after treatment but significantly decreased 6 months after treatment, warranting further investigation.
November 22, 2021
From baseline, all participants showed improvements on CGI-Improvement scale scores while all but 1 patient demonstrated improvement on modified Hoehn and Yahr scores.
November 17, 2021
The cell therapy is set to be evaluated in a 2-part, phase 1/2 trial.
October 20, 2021
Tofersen failed to meet its primary end point in change from baseline in ALSFRS-R but differences in total cerebrospinal fluid SOD1 protein and neurofilament light chain were observed.