BrainStorm Cell Therapeutics Archives - MedCity News https://medcitynews.com/tag/brainstorm-cell-therapeutics/ Healthcare technology news, life science current events Thu, 28 Sep 2023 01:33:46 +0000 en-US hourly 1 https://wordpress.org/?v=6.3.1 https://medcitynews.com/uploads/2021/03/cropped-mblue-32x32.png BrainStorm Cell Therapeutics Archives - MedCity News https://medcitynews.com/tag/brainstorm-cell-therapeutics/ 32 32 40682243 Brainstorm’s ALS Data Fail to Persuade FDA Advisors, Who Vote Down the Stem Cell Therapy https://medcitynews.com/2023/09/fda-advisory-committee-brainstorm-cell-therapeutics-als-stem-cell-therapy/ https://medcitynews.com/2023/09/fda-advisory-committee-brainstorm-cell-therapeutics-als-stem-cell-therapy/#respond Thu, 28 Sep 2023 01:33:46 +0000 https://medcitynews.com/?p=650064

NurOwn, Brainstorm Cell Therapeutics’ experimental stem cell therapy for ALS, did not win the backing of an independent panel of FDA advisors. Many advisory committee members said they want to see more data from another clinical trial, the same guidance the FDA has given the biotech for nearly three years.

]]> https://medcitynews.com/2023/09/fda-advisory-committee-brainstorm-cell-therapeutics-als-stem-cell-therapy/feed/ 0 650064 FDA Again Spurns BrainStorm’s ALS Data, This Time With Official Refusal https://medcitynews.com/2022/11/fda-again-spurns-brainstorms-als-data-this-time-with-official-refusal/ https://medcitynews.com/2022/11/fda-again-spurns-brainstorms-als-data-this-time-with-official-refusal/#respond Thu, 10 Nov 2022 19:50:12 +0000 https://medcitynews.com/?p=613072

BrainStorm Cell Therapeutics’ stem cell therapy for amyotrophic lateral sclerosis received an FDA refuse-to-file letter, correspondence that informs a company its application seeking approval is incomplete. The notice means BrainStorm might need to run another clinical trial.

]]> https://medcitynews.com/2022/11/fda-again-spurns-brainstorms-als-data-this-time-with-official-refusal/feed/ 0 613072 FDA calls out Brainstorm’s ALS stem cell therapy, says data don’t show benefit https://medcitynews.com/2021/03/fda-calls-out-brainstorms-als-stem-cell-therapy-says-data-dont-show-benefit/ https://medcitynews.com/2021/03/fda-calls-out-brainstorms-als-stem-cell-therapy-says-data-dont-show-benefit/#respond Wed, 03 Mar 2021 23:52:58 +0000 https://medcitynews.com/?p=517745 FDA sign, headquarters

A Brainstorm Cell Therapeutics therapy for Lou Gehrig’s disease failed a pivotal study, but the company points to better results in a subgroup. The FDA took the unusual step of publicly stating that study’s results do not show the stem cell therapy helps patients.

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