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Federal regulators are increasingly approving medicines before studies have shown they work, leaving patients at risk of taking prescriptions that could harm but not help them.
NEW YORK (Reuters) -U.S. Food and Drug Administration Commissioner Dr. Robert Califf said on Wednesday that he is very concerned about the prevalence of compounded and fake versions of highly in ...
The U.S. Food and Drug Administration (FDA) on Tuesday published letters warning two online vendors to stop selling unapproved versions of semaglutide and tirzepatide, the active ingredients in ...
banned.video banned.video Sister site of InfoWars. Warned by the US Food and Drug Administration for spreading misinformation on COVID-19 for "claims on videos posted on your websites that establish the intended use of your products and misleadingly represent them as safe and/or effective for the treatment or prevention of COVID-19." [130] [131 ...
The following are settlements reached with US authorities against pharmaceutical companies to resolve allegations of "off-label" promotion of drugs. Under the Federal Food, Drug, and Cosmetic Act, it is illegal for pharmaceutical companies to promote their products for uses not approved by the Food and Drug Administration (FDA), and corporations that market drugs for off-label indications may ...
Alpelisib is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.
The FDA said it found evidence the companies' websites offer the products, labeled for "research use only", for sale in the United States accompanied by claims such as weight loss, reducing the ...
In December 2014, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved olaparib as monotherapy. [ 7 ] [ 14 ] [ 13 ] [ 11 ] [ 12 ] The FDA approval is in germline BRCA mutated (gBRCAm) advanced ovarian cancer that has received three or more prior lines of chemotherapy.