Advisory Committee Archives - MedCity News https://medcitynews.com/tag/advisory-committee/ 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 Advisory Committee Archives - MedCity News https://medcitynews.com/tag/advisory-committee/ 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 often goes against advisory committee recommendations when votes are divided, study finds https://medcitynews.com/2019/07/fda-often-goes-against-advisory-committee-recommendations-when-votes-are-divided-study-finds/ https://medcitynews.com/2019/07/fda-often-goes-against-advisory-committee-recommendations-when-votes-are-divided-study-finds/#respond Tue, 16 Jul 2019 19:38:43 +0000 https://medcitynews.com/?p=464504

Although the agency goes against about one-fifth of AdCom recommendations, a study published Sunday only found one reliable variable predicting when that would happen.

]]> https://medcitynews.com/2019/07/fda-often-goes-against-advisory-committee-recommendations-when-votes-are-divided-study-finds/feed/ 0 464504 FDA expert panel questions Daiichi Sankyo leukemia drug data ahead of meeting https://medcitynews.com/2019/05/fda-expert-panel-questions-daiichi-sankyo-leukemia-drug-data-ahead-of-meeting/ https://medcitynews.com/2019/05/fda-expert-panel-questions-daiichi-sankyo-leukemia-drug-data-ahead-of-meeting/#respond Tue, 14 May 2019 12:10:42 +0000 https://medcitynews.com/?p=458501

A company spokesperson said the company was working to address the agency’s concerns about the drug, quizartinib, for FLT3-mutated acute myeloid leukemia.

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