FDA approves first biosimilar product Zarxio
The U.S. Food and Drug Administration today approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the U.S.
Archive for the ‘Food Safety News’ category
FDA expands approved use of Opdivo to treat lung cancer
The U.S. Food and Drug Administration today expanded the approved use of Opdivo (nivolumab) to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.
FDA launches drug shortages mobile app
Today, the U.S. Food and Drug Administration launched the agency’s first mobile application (app) specifically designed to speed public access to valuable information about drug shortages.
FDA approves new antibacterial drug Avycaz
The U.S. Food and Drug Administration today approved Avycaz (ceftazidime-avibactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including kidney infections (pyelonephritis), who have limited or no alternative treatment options.
FDA approves Farydak for treatment of multiple myeloma
The U.S. Food and Drug Administration today approved Farydak (panobinostat) for the treatment of patients with multiple myeloma.
FDA approves Farydak for treatment of multiple myeloma
The U.S. Food and Drug Administration today approved Farydak (panobinostat) for the treatment of patients with multiple myeloma.
FDA approves closure system to permanently treat varicose veins
The U.S. Food and Drug Administration today approved the VenaSeal closure system (VenaSeal system) to permanently treat varicose veins of the legs by sealing the affected superficial veins using an adhesive agent.
FDA permits marketing of first direct-to-consumer genetic carrier test for Bloom syndrome
The U.S. Food and Drug Administration today authorized for marketing 23andMe’s Bloom Syndrome carrier test, a direct-to-consumer (DTC) genetic test to determine whether a healthy person has a variant in a gene that could lead to their offspring inheriting the serious disorder.
Spiceco Issues A Correction Regarding Allergy Alert On Undeclared Peanut Allergen In 5 Oz. Containers Of Pride Of Szeged Sweet Hungarian Paprika Lot #091617PAHU05PS and Lot #091717PAHU05PS
Spiceco of Avenel, NJ is recalling PRIDE OF SZEGED SWEET HUNGARIAN PAPRIKA because it may contain undeclared Peanut Allergen. People who have an allergy or severe sensitivity to Peanut Allergen run the risk of serious or life-threatening allergic reaction if they consume this product. Read The Complete Story!
Spiceco Issues A Correction Regarding Allergy Alert On Undeclared Peanut Allergen In 5 Oz. Containers Of Pride Of Szeged Sweet Hungarian Paprika Lot #091617PAHU05PS and Lot #091717PAHU05PS
Spiceco of Avenel, NJ is recalling PRIDE OF SZEGED SWEET HUNGARIAN PAPRIKA because it may contain undeclared Peanut Allergen. People who have an allergy or severe sensitivity to Peanut Allergen run the risk of serious or life-threatening allergic reaction if they consume this product. Read The Complete Story!
Whole Foods Market’s Southwest Region Recalls Chocolate Cake For Two Due To Undeclared Egg
Whole Foods Market is recalling chocolate cake for two produced and sold in retail stores in the Southwest Region, which includes TX, OK, LA, AR, due to undeclared egg. People who have an allergy or severe sensitivity to egg run the risk of serious or life-‐‑threatening allergic reaction if they consume these products. Read The […]
Whole Foods Market’s Southwest Region Recalls Chocolate Cake For Two Due To Undeclared Egg
Whole Foods Market is recalling chocolate cake for two produced and sold in retail stores in the Southwest Region, which includes TX, OK, LA, AR, due to undeclared egg. People who have an allergy or severe sensitivity to egg run the risk of serious or life-‐‑threatening allergic reaction if they consume these products. Read The […]
Press Release for Hanbit Enterprises, Inc. dba Jack and the Beanstalk Recalls Soybean Sprouts Because of Possible Health Risk
Hanbit Enterprises, Inc. dba Jack and the Beanstalk is recalling Soybean Sprouts in 1lb, 1.5lb, 10 lb, and Natto plastic bags distributed up to and including February 12, 2015 with Best if Used by dates up to February 19, 2015, because they have the potential to be contaminated with Listeria monocytogenes, an organism which can […]
Moscahlades Bros Inc. Recalls Hellas Golden Double Smoked Herring Because of Possible Health Risk
Moscahlades Bros Inc. of Paterson, NJ is recalling Hellas Golden Double Smoked Herring because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled. Read The Complete Story!
FDA issues new draft documents related to compounding of human drugs
Today, the U.S. Food and Drug Administration issued five draft documents related to drug compounding and repackaging that will help entities comply with important public health provisions. The draft documents are applicable to pharmacies, federal facilities, outsourcing facilities and physicians.
FDA approves Lenvima for a type of thyroid cancer
The U.S. Food and Drug Administration today granted approval to Lenvima (lenvatinib) to treat patients with progressive, differentiated thyroid cancer (DTC) whose disease progressed despite receiving radioactive iodine therapy (radioactive iodine refractory disease).
California food company to cease operations for repeated food safety violations
A San Francisco, California-based food company, Fong Kee Tofu Co., Inc., and its owners, Jen Ying Fong, Suny Fong, and Yan Hui Fan, have agreed not to process or distribute food until it has been demonstrated to the U.S. Food and Drug Administration that its facility and practices comply with federal food safety requirements.
FDA permits marketing of fecal incontinence device for women
The U.S. Food and Drug Administration today allowed marketing of the Eclipse System for the treatment of fecal incontinence (FI) in adult women.
New data shows test can help physicians remove patients with suspected TB from isolation earlier
The FDA today cleared the Cepheid Xpert MTB/RIF Assay to help physicians determine if patients with suspected tuberculosis (TB) can be removed from airborne infection isolation. This expanded use allows healthcare providers to use one or two negative Xpert MTB/RIF Assay test results to help them determine whether a patient showing signs and symptoms of […]