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
Genetic Causes of Liver Disease in Obesity Identified
DNA methylation is related to liver disease known as non-alcoholic fatty liver disease among obese patients, research at The Translational Genomics Research Institute finds...
Strategies to Prevent Suicide among Cancer Patients
Strategies to prevent death by suicide among patients with cancer may include the use of comprehensive cancer centers and case managers for improved coordination of patient...
Cannabinoids for Cancer Treatment?
Cannabinoids may have a vast array of anti-cancer effects, a Rostock University Medical Center research finds. They may stop cancer cells from dividing and invading normal...
Sensitivity to Bitter-Taste may be Associated with Cancer Risk
Link found between high bitter-taste sensitivity and increased risk of cancer among older British women by a recent study that involves 5,500 women whose diet, lifestyle, and...
People who drink a cup of coffee first thing eat less breakfast
The findings clarify long-held but unqualified beliefs that coffee suppresses appetite, or that it aids metabolism - which has led to a boom in caffeine dietary supplements...
Tanning Beds at Gym May Up Skin Cancer Risk
Indoor tanning beds at the gym could increase skin cancer risk if used frequently. Tanning beds produce ultraviolet light which may be the cause for increasing the risk of...
Heart Patient's Discharged Against Advice More Likely to Return Within 30 Days
Heart attack patients who get themselves discharged against medical advice are more likely to return to the hospital in a hurry, finds a new study.
Giving adrenaline to cardiac arrest patients DOUBLES risk of brain damage
Officials are now reviewing the guidelines given to paramedics and ambulance staff, after the Warwick University study cast doubt on the way people have been treated for decades.
Water: The Key to Understanding Sweetness
Perception of sweetness may depend on molecular interactions between specific sugars and water in the saliva.
Strategies to Reduce Sugar-sweetened Beverage Consumption in Young Children
Consumption of sugar-sweetened beverages have been linked to weight gain and other negative health effects, particularly in young children. It is important to identify...