FDA approves new device for prevention of recurrent strokes in certain patients

The U.S. Food and Drug Administration today approved the Amplatzer PFO Occluder device. The PFO Occluder reduces the risk of a stroke in patients who previously had a stroke believed to be caused by a blood clot that passed through a small hole in the heart, called a patent foramen ovale (PFO), and then traveled to the brain.

Back to Nature Issues a Product Recall and Allergy Alert for Chocolate Chunk Cookies, Mini Chocolate Chunk Cookies and Chocolate Granola Due to Undeclared Milk

Back to Nature Foods, LLC is voluntarily recalling four (4) products because those products contain chocolate purchased from a third party supplier which was found to contain undeclared Milk that is not listed as an ingredient on the label.
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FDA grants accelerated approval to new treatment for advanced soft tissue sarcoma

The U.S. Food and Drug Administration today granted accelerated approval to Lartruvo (olaratumab) with doxorubicin to treat adults with certain types of soft tissue sarcoma (STS), which are cancers that develop in muscles, fat, tendons or other soft tissues. Lartruvo is approved for use with the FDA-approved chemotherapy drug doxorubicin for the treatment of patients with STS who cannot be cured with radiation or surgery and who have a type of STS for which an anthracycline (chemotherapy) is an appropriate treatment.

Medtronic Announces Voluntary Recall of its Pipeline Embolization Device, Alligator Retrieval Device, X-Celerator Hydrophilic Guidewire, Ultraflow and Marathon Flow Directed Micro Catheters

This voluntary recall is being conducted due to the potential separation and detachment of the polytetrafluoroethylene (PTFE) coating on parts of these devices. Should the PTFE separate from the delivery wire or stylets, PTFE particulate could enter the blood stream of the patient.

FDA awards 21 grants to stimulate product development for rare diseases

The U.S. Food and Drug Administration today announced that it has awarded 21 new clinical trial research grants totaling more than $23 million over the next four years to boost the development of products for patients with rare diseases. These new grants were awarded to principal investigators from academia and industry with research spanning domestic and international clinical sites.