FDA, Vanda
Nationwide Snack Recall Update As FDA Sets Highest Risk Level
The snacks now have a Class I risk level, meaning there is a "reasonable probability" they could cause "serious adverse ...
US FDA approves Zevra's treatment for rare genetic disease
The U.S. Food and Drug Administration approved Zevra Therapeutics' drug for a rare and fatal genetic disorder, making it the ...
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FDA’s new head of device safety held senior role at company troubled by safety warnings
“Olympus’ continued failure to meet FDA requirements demonstrates a troubling disregard for patient safety,” said Jeffrey ...
FiercePharma1h
After prior snub, Zevra clinches FDA approval for rare lysosomal storage disorder drug Miplyffa
For Zevra Therapeutics and its rare neurodegenerative disease med arimoclomol, the second time’s the charm. | The ...
FDA finds some 'dairy-free' chocolate products contain milk
Consumers should be aware that some chocolate labeled as "dairy-free" actually contains milk, the U.S. Food and Drug ...
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Wrap up: Elanco receives FDA approval for Zenrelia, and other veterinary news
Elanco announced this week that its product Zenrelia has received approval from the FDA. Zenrelia is a once a day orally, ...
The American Journal of Managed Care4h
FDA Approves Amivantamab for EGFR-Positive NSCLC With Exon 19 Deletion, Exon 21 L858R Substitution
The FDA approval of amivantamab-vmjw (Rybrevant) in combination with chemotherapy is the first targeted treatment to cut ...
FiercePharma6h
In addressing inspection shortfall, FDA says it's gaining more inspectors than it's losing
In its effort to play catch up after thousands of factory inspections were delayed during the coronavirus pandemic, the FDA ...