The U.S. Food and Drug Administration today granted accelerated approval to Zykadia (ceritinib) for patients with a certain type of late-stage (metastatic) non-small cell lung cancer (NSCLC).
Category Archives: Food Safety News
FDA approves first human papillomavirus test for primary cervical cancer screening
The U.S. Food and Drug Administration today approved the first FDA-approved HPV DNA test for women 25 and older that can be used alone to help a health care professional assess the need for a woman to undergo additional diagnostic testing for cervical cancer. The test also can provide information about the patient’s risk for developing cervical cancer in the future.
FDA approves Sylvant for rare Castleman’s disease
The U.S. Food and Drug Administration today approved Sylvant (siltuximab) to treat patients with multicentric Castleman’s disease (MCD), a rare disorder similar to lymphoma (cancer of the lymph nodes).
FDA proposes to extend its tobacco authority to additional tobacco products, including e-cigarettes
As part of its implementation of the Family Smoking Prevention and Tobacco Control Act signed by the President in 2009, the U.S. Food and Drug Administration today proposed a new rule that would extend the agency’s tobacco authority to cover additional tobacco products.
FDA proposes new expedited access program for medical devices that address unmet medical needs
Today, the U.S. Food and Drug Administration proposed a new program to provide earlier access to high-risk medical devices that are intended to treat or diagnose patients with serious conditions whose medical needs are unmet by current technology.
FDA approves Cyramza for stomach cancer
The U.S. Food and Drug Administration today approved Cyramza (ramucirumab) to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma, a form of cancer located in the region where the esophagus joins the stomach.
FDA approves Ragwitek for short ragweed pollen allergies
The U.S. Food and Drug Administration today approved Ragwitek, the first allergen extract administered under the tongue (sublingually) to treat short ragweed pollen induced allergic rhinitis (hay fever), with or without conjunctivitis (eye inflammation), in adults 18 years through 65 years of age.
FDA discourages use of laparoscopic power morcellation for removal of uterus or uterine fibroids
In a safety communication notice issued today, the U.S. Food and Drug Administration discouraged the use of laparoscopic power morcellation for the removal of the uterus (hysterectomy) or uterine fibroids (myomectomy) in women because, based on an analysis of currently available data, it poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus.
Puerto Rico bakery agrees to stop manufacturing and distributing products
Los Genuinos, Inc., a Bayamon, Puerto Rico, food manufacturer, has agreed under terms of a court order not to process or distribute food until it addresses the unsanitary conditions found by U.S. Food and Drug Administration investigators. The company must also correct its product labels to accurately reflect the ingredients used in its products.
FDA approves Tanzeum to treat type 2 diabetes
The U.S. Food and Drug Administration today approved Tanzeum (albiglutide) subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.