News

FDA denies ultra-rare drug but offers path to ‘yes’
The FDA rejected Stealth BioTherapeutics’ latest bid to market its proposed treatment for an ultra-rare genetic condition, ...
Sleep Better Columbus Expands Access to FDA-Cleared Oral Appliance Therapy for Mild to Moderate Sleep Apnea
Sleep Better Columbus is now offering FDA-cleared oral appliance therapy for patients diagnosed with mild to moderate ...
Tomato recall update as FDA issues highest warning level
The Centers for Disease Control and Prevention has estimated that salmonella causes about 420 deaths annually in the U.S.
Stealth Bio to cut jobs after FDA rejects therapy for rare disorder
By Sriparna Roy (Reuters) -Privately held Stealth BioTherapeutics said on Thursday the U.S. Food and Drug Administration had ...
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FDA approves 1st blood test to diagnose Alzheimer's disease
U.S. health officials have endorsed the first blood test that can help diagnose Alzheimer’s disease. The Food and Drug ...
Seattle weight loss patients fret over FDA limits on off-brand drugs
As the Food and Drug Administration clamps down on off-brand weight loss medications, Seattle-area residents are stocking up ...
FDA-approved colon cancer blood test now available across Georgia amidst rising cancer rates
ATLANTA, Ga. (WRDW/WAGT) - Colorectal cancer is the second-deadliest form of cancer in Georgia, with an estimated 4,940 new ...
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Are FDA Review Timelines Slipping? What Companies Need to Know
As noted in our earlier alert, the FDA continues to face mounting internal pressure, ranging from staffing reductions and ...