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FDA names former pharmaceutical company executive to oversee US drug program
The Food and Drug Administration named a longtime pharmaceutical executive to run the agency’s drug program. Dr.
FDA Elevates Dubai Chocolate Spread Recall to Class 1 Over Salmonella Risk
Salmonella can cause serious and potentially fatal infections in young children, the frail or elderly, and others with ...
FDA Suspends Muscular Dystrophy Drug After 3 Patient Deaths
The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...
Fierce Biotech6m
Sarepta LGMD trials all hit by FDA hold amid newly surfaced safety concerns over gene therapy
The Sarepta saga continues, with the FDA slapping a clinical hold across all of the company’s investigational limb girdle ...
FDA recalls over 67,000 cases of Power Stick deodorant due to manufacturing violations
On July 10, Pennsylvania-based health and beauty manufacturer A.P. Deauville announced a recall of 67,214 cases of its Power ...
Fierce Pharma8m
Lundbeck, Otsuka's PTSD bid for Rexulti dealt a setback at FDA advisory committee
The prospect of Lundbeck and Otsuka’s Rexulti becoming part of a new treatment for post-traumatic stress disorder (PTSD) ...
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FDA to appoint George Tidmarsh as top drug regulator, Bloomberg News reports
U.S. Food and Drug Administration commissioner Marty Makary has chosen former biotech executive George Tidmarsh as the ...
FDA Greenlights Game-Changing UV Technology That Could Make Raw Milk Safer to Consume
Tamarack Biotics’ TruActive process targets pathogens with UV light while keeping the milk’s enzymes and proteins intact.
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Sarepta stands behind Elevidys after FDA requests gene therapy be pulled from market
As the controversy over the safety of Sarepta Therapeutics’ gene therapies comes to a head, the biotech is standing firm ...
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Juul’s FDA approval doesn’t clear fog of e-cigarette risks, especially for teens
The Food and Drug Administration has granted permission for Juul to continue selling its e-cigarettes, offering some reprieve ...