The U.S. Food and Drug Administration Thursday approved Takhzyro (lanadelumab), the first monoclonal antibody approved in the U.S. to treat patients 12 years and older with types I and II hereditary angioedema (HAE), a rare and serious genetic disease that affects people with low levels of and poorly functioning C1-INH proteins in the body. This…
FDA Approves First Drug for Rare Neurotrophic Keratitis Eye Disease
The U.S. Food and Drug Administration Wednesday approved the first drug, Oxervate (cenegermin), for the treatment of neurotrophic keratitis, a rare disease affecting the cornea (the clear layer that covers the colored portion of the front of the eye). “While the prevalence of neurotrophic keratitis is low, the impact of this serious condition on an…
FDA Warns Of Imposters Sending Consumers Fake Warning Letters
The U.S. Food and Drug Administration is warning consumers about criminals forging FDA warning letters to target individuals who tried to purchase medicines online or over the phone. Based on the agency’s experience with criminals posing as FDA employees, the FDA is concerned that these fake warning letters are linked to an international extortion scam.…
FDA Warns Of Fraudulent And Unapproved Flu Products
As part of the U.S. Food and Drug Administration’s ongoing efforts to protect consumers from health fraud, the agency is reminding consumers to be wary of unapproved products claiming to prevent, treat or cure influenza, or flu. This year’s severe flu season raises new concerns about the potential for consumers to be lured into buying…
Primus Recalling All Unexpired Lots Of Limbrel Due To ‘Adverse Event’ Reports
Primus Pharmaceuticals, Inc. of Scottsdale, AZ is voluntarily recalling all unexpired lots of Limbrel products to the patient (user/consumer) level at FDA’s request. FDA has requested a recall of Limbrel due to rare but serious and reversible side effects associated with Limbrel. Between January 1, 2007, and November 9, 2017, FDA received 30 adverse event…
Authorities Warn Companies Selling Unapproved Opioid Cessation Products
The U.S. Food and Drug Administration and the Federal Trade Commission posted joint warning letters to the marketers and distributors of 12 opioid cessation products, for illegally marketing unapproved products with claims about their ability to help in the treatment of opioid addiction and withdrawal. “The FDA is increasingly concerned with the proliferation of products claiming…
FDA Warns American CryoStem Over Unapproved Stem Cell Product
FDA warns American CryoStem Corporation of significant deviations related to its unapproved stem cell product, Atcell. The U.S. Food and Drug Administration on Thursday posted a warning letter issued to American CryoStem Corporation of Monmouth Junction, NJ and its Chairman/Chief Executive Officer, John S. Arnone, for marketing an adipose derived stem cell product without FDA approval and for significant deviations…
FDA OKs First Biosimilar For The Treatment Of Certain Breast And Stomach Cancers
The U.S. Food and Drug Administration approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+). Ogivri is the first biosimilar approved in the U.S. for the treatment of breast cancer or stomach cancer…
