Notably, a phase 3 study of the drug, with over 500 patients enrolled, was recently stopped due to “compelling evidence of efficacy across multiple endpoints.”. The FDA Just Approved Winlevi, a New Topical Treatment for Acne Kaleigh Fasanella 8/30/2020 At current rate, it'll be 10 years before Americans are adequately vaccinated against Covid Upneeq will be available in a preservative-free solution. So far, the agency has approved 16 new drugs in 2020. Isturisa (osilodrostat, Recordati) is the first FDA-approved drug to inhibit the overproduction of cortisol by blocking 11-beta-hydroxylase, an enzyme involved in cortisol synthesis. It is a selective catechol-O-methyltransferase (COMT) inhibitor for use as FDA update: New gastro drugs approved in 2020, Unconventional COVID-19 cures that might actually work. Certain drugs are classified as new molecular entities (“NMEs”) for purposes of FDA … The following database contains a listing of drugs approved by the Food and Drug Administration (FDA) for sale in the United States. After approval, FDA follow-up continues to make sure new drugs continue to be safe and effective. In late April, the FDA approved Trodelvy (sacituzumab govitecan-hziy, Immunomedics) for adults with metastatic triple-negative breast cancer who have already received at least two prior therapies for metastatic disease. Encorafenib On April 8, 2020, the FDA cleared encorafenib plus cetuximab for the treatment of adult patients with metastatic colorectal cancer (CRC) harboring a BRAF V600E mutation, detected by an FDA-approved test, following prior therapy. New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products, Recalls, Market Withdrawals and Safety Alerts, New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products, Center for Biologics Evaluation and Research, To treat actinic Keratosis of the face or scalp, To treat patients with hereditary angioedema, For detection and localization of prostate cancer, To treat high-risk refractory or relapsed neuroblastoma, To treat obesity and the control of hunger associated with pro-opiomelanocortin deficiency, a rare disorder that causes severe obesity that begins at an early age, atoltivimab, maftivimab, and odesivimab-ebgn, To help detect certain types of neuroendocrine tumors, To treat neuromyelitis optica spectrum disorder, To treat Chagas disease in certain pediatric patients younger than age 18, To treat relapsed or refractory diffuse large B-cell lymphoma, To treat adult patients with myelodysplastic syndromes, To treat molecularly long-chain fatty acid oxidation disorders, To treat metastatic small cell lung cancer, Diagnostic agent for patients with Alzheimer’s disease, Diagnostic imaging agent for certain patients with breast cancer, To treat advanced gastrointestinal-stromal tumors, To treat patients with non small cell lung cancer, To treat patients with Parkinson’s disease experiencing “off” episodes, To treat adult patients with metastatic triple-negative breast cancer who received at least two prior therapies for metastatic disease, To treat certain patients with cholangiocarcinoma, a rare form of cancer that forms in bile ducts, To treat advanced unresectable or metastatic HER2-positive breast cancer, To treat neurofibromatosis type 1, a genetic disorder of the nervous system causing tumors to grow on nerves, To treat relapsing forms of multiple sclerosis, To treat adults with Cushing’s disease who either cannot undergo pituitary gland surgery or have undergone the surgery but still have the disease, To help prevent nausea and vomiting after surgery, For the preventive treatment of migraine in adults, To treat adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C, To treat chronic idiopathic constipation (CIC) in adults, To treat adults with unresectable or metastatic gastrointestinal stromal tumor (GIST), Some of these products are innovative new products that never have been used in clinical practice. 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