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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The headlines of Master Doctor
Split Liver Transplants Could Safely Help Sickest Children, Says Study
The type of patient who is most likely to survive a split liver transplant has been identified by researchers.
Higher Intake of Green Leafy Vegetables may Prevent Fatty Liver Disease
Higher intake of green leafy vegetables in your daily diet may prevent the risk of developing fatty liver disease or liver steatosis, finds a new study.
U.S. Immigration and Customs Enforcement appears to be gearing up for...
Anyone who doesn't yet realize the U.S. government is gearing up to defend America against a major land invasion of foreign nationals needs to look at this press release from...
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Peppermint oil is an extremely versatile oil that is commonly found in many holiday-themed products, whether it be candies, candles, or shower gels. But even before people...
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People are less inclined to buy chocolate bars while in queues to eat 'on the go'. A total of 17% fewer items were taken home after policies were introduced in six British...
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The sale of e-cigarettes to those under 18 is illegal under federal law.
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