Evolus Vows To Move Forward As FDA Fails To Approve Its Neurotoxin
The approval of Evolus' DWP-450 has hit a snag, repotedly due to concerns at the Daewoong manufacturing facility slated to create the product. The U.S. Food & Drug Administration issued a complete response letter to the company's biologic license application for DWP-450 outlining concerns that must be addressed before the FDA can approve the new neurotoxin for marketing in the U.S.
In a call to investors and publicly released statement, the company did not elaborate on the FDA's concerns other than to note that the deficiencies cited related to Chemistry, Manufacturing, and Controls processes, not clinical performance of the product.
“We are pleased with the progress we continue to make with the FDA, and this CRL confirms our confidence in our clinical submission. Deficiencies cited within the CRL are isolated to CMC matters and we expect to respond comprehensively within 90 days,” said David Moatazedi, president and CEO of Evolus. “Overall, we view these updates as positive,...
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Community pharmacies helps to screen patients for type 2 diabetes, which could increase early diagnosis and reduce health care expenses.
Diabetes Treatment May Keep Dementia and Alzheimer's at Bay
Dementia and Alzheimer's develop much faster in people with untreated diabetes. However, patients on medication for type 2 diabetes can keep dementia and Alzheimer's at bay.
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Do you have a fussy baby at home? Mothers of fussy babies are more likely to develop depression symptoms, reveals a new study.
Bacteria can Travel Thousands of Miles Globally Through the Air
Bacteria may travel thousands of miles through the air worldwide instead of hitching rides with people and animals, reveals a study.
Replacing Sitting Time with Light Physical Activity Lowers Death Risk
Do you like sitting around? A new study found that swapping 30 minutes of sitting time with light physical activity can reduce the risk of early death by 50 percent.
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