WebThe committee will discuss new drug application (NDA) 215887, for tofersen (BIIB067) intrathecal injection, submitted by Biogen Inc., for the treatment of amyotrophic lateral sclerosis (ALS ... WebMar 22, 2024 · CAMBRIDGE, Mass., March 22, 2024 (GLOBE NEWSWIRE) — Biogen Inc. ( Nasdaq: BIIB) announced today the outcome of the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee meeting on tofersen, an investigational product for the treatment of superoxide dismutase 1 (SOD1) …
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WebIn a press release published on 17 October 2024 Biogen announced their phase 3 trial for tofersen (VALOR) did not meet its primary endpoint. However, signs of reduced disease progression were seen across multiple secondary and exploratory endpoints, including respiratory function and reduced levels of SOD1 in the CSF. WebOn July 26, 2024, it was announced that the U.S. Food and Drug Administration (FDA) accepted Biogen’s New Drug Application for tofersen and granted it Priority Review with an action date of January 25, 2024. … WebOct 18, 2024 · Biogen has pointed to positive trends on multiple secondary measures including measures of motor and respiratory function, muscle strength and quality-of-life in the 108-subject study that it says ... flower shop culver city ca