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
New Obesity Treatment: Brain Stimulation May Reduce Food Cravings
Obesity treatment by stimulating the brain to alter its intrinsic reward system which may reduce food cravings. Deep Transcranial Magnetic Stimulation , a medical treatment...
People with large waistlines have lower levels of vitamin D, study finds
Researchers from the VU University, Amsterdam, found obese people who carry excess fat around their midriffs have lower vitamin D levels. Liver fat is associated with low...
Nanoparticles Produced from Tea Leaves Inhibit Lung Cancer
Quantum dots, derived from tea leaves extract were found to inhibit the growth of lung cancer cells in a recent study.
Extreme fasting didn't suit rats but my new 5:2 diet's good for us, says...
Could some fasting diets increase the risk of type 2 diabetes? That was the question posed by scientists last week, after researchers unveiled evidence that seemed to suggest...
Blood test for prostate cancer could eliminate the need for almost half of...
US researchers have come up with a potential replacement for the unreliable PSA blood test currently used on the NHS in Britain, which can be wrong three out of four times.
Does an Infection Blood Test Reduce Antibiotic Prescription?
Procalcitonin guideline has little overall impact on whether or not the physicians prescribed antibiotics, shows study.
Drug Abuse may Really Set In If Kids Start Smoking Pot Before 15
Drug abuse may become a real problem at the age of 28 if kids start smoking pot before 15, finds a new study. These kids are bound to have drug problems when they become young...
Theresa May to announce how artificial intelligence will save '22,000 lives...
Theresa May will claim in a speech advances in artificial intelligence will mean cancer patients will get five more years of healthy, independent life by 2035, and thousands...
Optimal Treatment of Sleep Apnea Reduces Cardiovascular Risk in Prediabetic...
Optimal treatment of sleep apnea reduces cardiovascular risk in those with prediabetes, shows study.
Asthma Development Risk Higher in Children Exposed to Ozone at Birth
Exposure to ozone at birth resulted in an increased risk of developing asthma by the time the child turns 3 years of age, finds news study.