The Phase I trial will recruit participants who have been diagnosed with non-arteritic anterior ischaemic optic neuropathy ...
Jan 28 (Reuters) - Regenxbio said on Wednesday the U.S. Food and Drug Administration has placed a clinical hold on two of its ...
The FDA has granted breakthrough therapy designation for litifilimab in patients with cutaneous lupus erythematosus, according to a press release from manufacturer Biogen. Litifilimab (Biogen) is a ...
In December 2024, RevBio received approval from the FDA to expand an ongoing clinical trial of Tetranite. "RevBio receives FDA clearance for cranial bone glue trial" was originally created and ...
A central nervous system (CNS) tumor has prompted the FDA to place clinical holds on two Regenxbio gene therapies, including ...
The FDA approved a fixed-dose combination of carbachol and brimonidine tartrate for presbyopia, offering a noninvasive alternative to glasses or surgery. Phase 3 trials demonstrated superior ...
The Food and Drug Administration paused trials for two experimental gene therapies from Regenxbio after one child developed a ...
The development of a brain tumor in a study participant led regulators to suspend a Hurler syndrome therapy in early testing ...
Unicycive Therapeutics (UNCY) stock gains as the resubmitted marketing application for the kidney disease drug undergoes FDA review. Read more here.
Jan 27 (Reuters) - Intellia Therapeutics said on Tuesday that the U.S. drug regulator has lifted a clinical hold on one of ...
The U.S. Food and Drug Administration (FDA) is celebrating a historic milestone in 2026, marking 120 years of national ...
Charlie Paterson, partner at PA Consulting, explains how reduced FDA capacity and staff turnover have led to longer regulatory timelines, increased preparation for agency interactions, and delayed ...
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