Amyotrophic lateral sclerosis (ALS), formerly known as Lou Gehrig’s disease, is a progressive and fatal neurodegenerative disorder with no known cure. While three therapies have gained U.S. FDA approvals to date, including Rilutek (riluzole), Radicava/Radicava ORS (edaravone) and tofersen (BIIB-067, the lack of a disease-modifying drug has spurred the continual search for novel therapies.

While U.S. policymakers are scaling back funding on mRNA vaccine research, Australia is accelerating investment in the technology. At the center of this effort is Moderna Inc., which is establishing an mRNA research and manufacturing footprint in the country and banking on decades of local expertise to bring new therapies to the clinic and serve as a regional hub for Asia Pacific.

The U.S. FDA cleared 18 drugs in August, comparable to July’s 17 but down from June’s 23 approvals. That brings the 2025 U.S. total through August to 143, matching 2020 as the second-highest count on record for BioWorld for the period, after 2024’s high of 159.

“The comment I hear a lot from scientists … is that science has no borders,” Arif Noorani, partner at Sidley Austin LLP, said while addressing the panel audience at Asia Bio 2025 in Singapore. “I agree, but the reality is, we do have a lot of borders.”