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FDA commissioner predicts ‘incredible cures’ within two years

"We are advancing cures and meaningful treatments at record speed at the FDA," Makary said on “Katie Pavlich Tonight.” ...
STAT

FDA halts gene therapy trials after brain tumor found in patient

The Food and Drug Administration paused trials for two experimental gene therapies from Regenxbio after one child developed a ...
Becker's Hospital Review

FDA fast-tracks ADHD drug for priority review

The FDA has accepted Otsuka’s New Drug Application for centanafadine, a first-in-class norepinephrine, dopamine and serotonin reuptake inhibitor (NDSRI) for the treatment of attention-deficit ...

Intellia gets FDA nod to resume one gene therapy trial after safety pause

Intellia Therapeutics said on Tuesday that the U.S. drug regulator has lifted a clinical hold on one of its late-stage gene ...

REGENXBIO: Key FDA Decision On Hunter Syndrome Just Weeks Away

Regenxbio Inc. faces pivotal catalysts in 2026, notably RGX-121's FDA decision and RGX-202 Duchenne data, potentially ...
The Manila Times

Biogen’s Litifilimab Receives FDA Breakthrough Therapy Designation for Cutaneous Lupus Erythematosus, a Disease With No Targeted Treatment Options

Designation is based on the breadth of available litifilimab data, including the Phase 2 LILAC study result that showed ...