GlobalData on MSN
FDA puts REGENXBIO gene therapy trials on hold after brain tumour
A five-year-old patient dosed with RGX-111 has developed a brain tumour four years after being dosed with the gene therapy.
A central nervous system (CNS) tumor has prompted the FDA to place clinical holds on two Regenxbio gene therapies, including ...
GlobalData on MSN
FDA accepts Otsuka’s centanafadine application for ADHD treatment
The Prescription Drug User Fee Act target action date for the NDA is scheduled for 24 July 2026.
The Food and Drug Administration paused trials for two experimental gene therapies from Regenxbio after one child developed a ...
The Cool Down on MSN
Grocery store chain issues recall for thousands of gallons of water due to startling FDA report: 'Floating black foreign substance'
"I am concerned." Grocery store chain issues recall for thousands of gallons of water due to startling FDA report: 'Floating ...
In November, six months after KJ’s debut, top Food and Drug Administration officials Marty Makary and Vinay Prasad published ...
Even as Johnson & Johnson’s oncology superstar Darzalex Faspro racks up megablockbuster sales and reshapes the multiple ...
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 ...
On January 6, 2026, the U.S. Food & Drug Administration (FDA) updated two guidance documents, General Wellness: Policy for ...
The McCafé Decaf K-Cups may actually contain caffeine, which can lead to adverse health effects. The FDA gave the recall the ...
The FDA has lifted a clinical hold on Intellia Therapeutics’ Magnitude-2 phase 3 trial of nexiguran ziclumeran, or nex-z: a CRISPR-based gene therapy for patients with hereditary transthyretin ...
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