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
HPV vaccine IS safe: Analysis finds no unexpected side effects
Research by the Centers for Disease Control and Prevention in the US studied the reactions of more than 700,000 people who received the vaccine against HPV strains 16 and 18.
Hormone that makes women more fertile is linked to breast cancer risk
Researchers from New York University School of Medicine examined blood samples from almost 6,000 premenopausal women across the US and Europe.
Supplementing with inulin improves your cholesterol levels
Diet plays a significant role in reducing one's risk for cardiovascular disease. In a study published in the journal Nutrition, Belgian scientists demonstrated that the...
Eating healthy foods and cutting out junk DOES cut your risk of developing...
Researchers at the French Institute for Health and Medical Research studied the diets of more than 470,000 Europeans to discover those with fattier diets have a an 11 per cent...
Give millions of patients already on statins a new type of drug
Cambridge University researchers tested the effects of LPL enhancers using genetic data of around 400,000 people. The results were published in JAMA Cardiology.
Pregnant women warned 'eating for two' increases diabetes risk
A survey of 900 women has found a link to children who developed insulin resistance - a key precursor of diabetes - at age seven. There was also a link to obesity and high...
Mother's trauma is as damaging as SMOKING for unborn babies
Past trauma coupled with high stress hormone levels in pregnancy were linked to 1.3 oz lower birth weights for baby boys, raising risks for disease and growth delays, a new Mt...
Two design student friends create 3D-printed PINK prosthetic breasts
Rosie Brave and Sam Jackman, both design students at Plymouth University, hope their invention will replace the 'bland' beige prosthetics dished out by the NHS.
Thermal Ablation as a First Step in Treating Early-stage Lung Cancer
Lung cancer treatment using thermal ablation is a safe and effective option compared to radiation for patients with early-stage lung cancer who cannot undergo surgery, says study.
Monitoring Serum Albumin Can Help Patients Recover from Gastrectomy: Study
Postoperative pulmonary complications may lead to increased death risk and prolonged hospital stay in surgical patients with gastric cancer. Therefore, monitoring serum albumin...