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A Phase 1b clinical trial evaluating the safety and pharmacological profile of DNL343, Denali Therapeutics’ investigational oral therapy, in adults with amyotrophic lateral sclerosis (ALS) has started dosing participants. The study (NCT05006352) is currently recruiting patients at the Centre for Human Drug Research (CHDR) in Leiden, Netherlands.
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Amylyx Pharmaceuticals plans to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) in the coming months for approval of its investigational oral therapy AMX0035 for amyotrophic lateral sclerosis (ALS). The decision follows recent discussions with the FDA, including a pre-NDA meeting held…
A newly launched non-profit institute is seeking to advance research, and the development of new therapies, for people with rare diseases — a patient community with some of the largest therapeutic needs, but one that is often left behind. Named the Institute for Life Changing Medicines, the project was…
The last patient visit has been completed in Clene’s Phase 2 trial investigating the potential of CNM-Au8 — which uses nanotechnology to prevent the loss of motor neurons — for the treatment of amyotrophic lateral sclerosis (ALS). A total of 45 people with the neurological disorder had been…
Columnist Kristin Neva narrates several hours of a typical day, which includes shopping and performing an assist cough on her husband, Todd.
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