Improvements – Talk Bio

FDA Policy Tracker: 2025 Was a Year of Change

3 weeks ago talkbio0Tagged 2025, Drug Approval, Food Safety, GRAS Reform, Improvements, Mental Recall, Trump administration, United States Food and Drug Administration

FDA; 2025; Trump Administration; Food Safety; FSMA 204; GRAS Reform; Drug Approvals; Recall Improvements

Avidity Touts Functional Improvements for DMD Therapy, Clearing Way to FDA

5 months ago talkbio0Tagged Approved, Avidity, Biosciences, Blackfoot language, Breakthrough Therapy, Clinical Trials, Functional, Improvements, Muscular Dystrophy, Duchenne, skipping, Submission, United States Food and Drug Administration

Avidity Biosciences; del-zota; DMD; Duchenne muscular dystrophy; FDA approval; functional improvements; exon 44 skipping; Breakthrough Therapy; clinical trial; BLA submission

Akero Reinforces Phase III FGF21 Analog Candidate with Enhanced Fibrosis Response Rates in MASH Data Update

2 years ago talkbio0Tagged Analog, Antibody-Drug, Efruxifermin, fibroblast growth factor 21, Fibrosis Response Rate, Improvements, metabolic dysfunction-associated steatohepatitis, Phase IIb HARMONY Study, Statistical Significance

Akero Therapeutics, FGF21 Analog, efruxifermin (EFX), Metabolic Dysfunction-Associated Steatohepatitis (MASH), Phase IIb HARMONY Study, Fibrosis Response Rate, 96 Weeks, Statistically Significant Improvements