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.
Category Archives: Drug Safety Information Podcasts
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.
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.
FDA warns against the use of homeopathic teething tablets and gels
The U.S. Food and Drug Administration is warning consumers that homeopathic teething tablets and gels may pose a risk to infants and children. The FDA recommends that consumers stop using these products and dispose of any in their possession.
FDA Statement from Todd Simpson, FDA Chief Information Officer (CIO) on GAO Report Regarding FDA’s IT Security Program
Information security and the protection of industry and public health information are among the FDA’s highest priorities and we do not take lightly the recommendations provided by the GAO in its June 2016 report.
FDA approves first automated insulin delivery device for type 1 diabetes
The U.S. Food and Drug Administration today approved Medtronic’s MiniMed 670G hybrid closed looped system, the first FDA-approved device that is intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses in people 14 years of age and older with type 1 diabetes.
FDA approves expanded indications for Ilaris for three rare diseases
The U.S. Food and Drug Administration today approved three new indications for Ilaris (canakinumab). The new indications are for rare and serious auto-inflammatory diseases in adult and pediatric patients:
FDA approves Amjevita, a biosimilar to Humira
The U.S. Food and Drug Administration today approved Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases.
FDA launches competition to spur innovative technologies to help reduce opioid overdose deaths
The U.S. Food and Drug Administration today announced the 2016 Naloxone App Competition, a public contest focused on developing innovative technologies to combat the rising epidemic of opioid overdose.
FDA launches competition to spur innovative technologies to help reduce opioid overdose deaths
The U.S. Food and Drug Administration today announced the 2016 Naloxone App Competition, a public contest focused on developing innovative technologies to combat the rising epidemic of opioid overdose.