Browsing Tag
FDA
341 posts
uniQure moves closer to FDA approval as AMT-130 gene therapy shows progress for Huntington’s disease
Find out how uniQure’s AMT-130 regulatory path for Huntington’s disease is evolving after the FDA’s latest feedback on its data sufficiency.
FDA lifts hold on Rein Therapeutics’ LTI-03 trial, reviving hopes for idiopathic pulmonary fibrosis treatment
FDA clears Rein Therapeutics to restart its Phase 2 trial of LTI-03 for idiopathic pulmonary fibrosis, restoring investor confidence and trial momentum.
FDA accepts Alvotech and Teva’s BLA for AVT05, advancing first golimumab biosimilar in the U.S.
FDA accepts Alvotech and Teva’s BLA for AVT05, a proposed golimumab biosimilar — find out how this milestone strengthens U.S. biosimilar competition.
Bioxytran reports successful clinical trial for ProLectin-M, a broad-spectrum antiviral targeting multiple respiratory viruses
Find out how Bioxytran’s completed randomized trial for ProLectin-M could redefine the antiviral market and reshape biotech investor sentiment.
FDA grants priority review for BioMarin’s PALYNZIQ to treat adolescents with phenylketonuria (PKU)
Find out how BioMarin’s PALYNZIQ priority review could transform PKU treatment for adolescents and reshape the company’s rare-disease strategy.
Breakthrough trial: Oncolytics Biotech’s pelareorep combo doubles response rate in advanced anal cancer
Find out how Oncolytics Biotech’s breakthrough trial doubled response rates in advanced anal cancer and set up a 2026 FDA path.
This ear-worn device just got FDA clearance to treat kids’ gut pain—What NeurAxis did right
NeurAxis gains FDA clearance for IB-Stim in treating pediatric gut disorders. Find out what this means for investors and the medtech market now.
FDA clears Mode Sensors’ wearable for fluid monitoring: Can Re:Balans redefine hospital care?
FDA clears Mode Sensors’ Re:Balans wearable for fluid monitoring. Explore how this innovation could transform hospital care and digital health in 2025.
FDA approves Bayer’s Lynkuet, a first-in-class dual NK-1/NK-3 antagonist for menopausal hot flashes
Find out how Bayer’s Lynkuet is changing menopause care with the first dual-neurokinin receptor antagonist approved by the FDA for hot flashes!
Scienture starts commercial rollout of Arbli, the first FDA-approved losartan oral suspension
Find out how Scienture is changing the hypertension treatment market with the FDA-approved Arbli losartan oral suspension.