October 19, 2013
The U.S. Food and Drug Administration today approved Opsumit (macitentan), a new drug to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive and debilitating disease that can lead to death or the need for lung transplantation.
Read more here…
October 10, 2013
The U.S. Food and Drug Administration today approved Liposorber LA-15 System to treat pediatric patients with primary focal segmental glomerulosclerosis (FSGS) either before transplant, or after renal (kidney) transplantation in which there is recurrence of FSGS.
Read more here…
October 8, 2013
The U.S. Food and Drug Administration today approved Adempas (riociguat) to treat adults with two forms of pulmonary hypertension.
Read more here…
October 4, 2013
The U.S. Food and Drug Administration today approved Clinolipid (lipid injectable emulsion, USP) for intravenous feeding (parenteral nutrition) in adult patients, providing a source of calories and essential fatty acids for adult patients who are unable to eat or drink.
Read more here…
October 1, 2013
The U.S. Food and Drug Administration today approved Brintellix (vortioxetine) to treat adults with major depressive disorder.
Read more here…
September 30, 2013
The U.S. Food and Drug Administration today granted accelerated approval to Perjeta (pertuzumab) as part of a complete treatment regimen for patients with early stage breast cancer before surgery (neoadjuvant setting). Perjeta is the first FDA-approved drug for the neoadjuvant treatment of breast cancer.
Read more here…
September 26, 2013
The U.S. Food and Drug Administration today announced it has awarded seven grants totaling more than $3.5 million to various pediatric device consortia to boost the development and availability of medical devices for children.
Read more here…
September 24, 2013
Today, the U.S. Food and Drug Administration issued final guidance for developers of mobile medical applications, or apps, which are software programs that run on mobile communication devices and perform the same functions as traditional medical devices. The guidance outlines the FDA’s tailored approach to mobile apps.
Read more here…
September 24, 2013
The U.S. Food and Drug Administration today approved revised labeling for the Sapien Transcatheter Heart Valve (THV), making the device available to an expanded group of patients who have inoperable aortic valve stenosis, a disease of the heart valves that causes narrowing of the aortic valve, restricting blood flow from the heart.
Read more here…
September 21, 2013
U.S. Marshals seized food products at Gourmet Provisions, LLC and Royal Cup, Inc., after U.S. Food and Drug Administration investigators found widespread and active rodent and insect infestation on the premises.
Read more here…
September 21, 2013
Today, the U.S. Food and Drug Administration announced a final rule for the unique device identification system (UDI) that, once implemented, will provide a consistent way to identify medical devices.
Read more here…
September 19, 2013
The U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) today, as part of an on-going interagency partnership, have awarded a total of up to $53 million to fund tobacco-related research in fiscal year 2013 to create 14 Tobacco Centers of Regulatory Science (TCORS).
Read more here…
September 18, 2013
The U.S. Food and Drug Administration announced today that federal judge Algenon L. Marbley of the Southern District of Ohio has approved a consent decree of permanent injunction against Shamrock Medical Solutions Group, LLC, of Lewis Center, Ohio, and four of its corporate officers and employees for continued drug manufacturing and labeling violations that resulted […]
Read more here…
September 16, 2013
The U.S. Food and Drug Administration today issued an import alert under which U.S. officials may detain at the U.S. border drug products manufactured at Ranbaxy Laboratories, Ltd.’s facility in Mohali, India. The firm will remain on the import alert until the company complies with U.S. drug manufacturing requirements, known as current good manufacturing practices […]
Read more here…
September 16, 2013
The U.S. Food and Drug Administration today approved the first generic version of Xeloda (capecitabine), an oral chemotherapy pill used to treat cancer of the colon or rectum (colorectal cancer) that has spread to other parts of the body (metastatic), and metastatic breast cancer.
Read more here…
September 13, 2013
The U.S. Food and Drug Administration today authorized the marketing of the UroLift system, the first permanent implant to relieve low or blocked urine flow in men age 50 and older with an enlarged prostate.
Read more here…
September 11, 2013
The U.S. Food and Drug Administration today approved a new use for Botox Cosmetic (onabotulinumtoxinA) for the temporary improvement in the appearance of moderate to severe lateral canthal lines, known as crow’s feet, in adults. Botox Cosmetic is the only FDA approved drug treatment option for lateral canthal lines.
Read more here…
September 10, 2013
The U.S. Food and Drug Administration today announced class-wide safety labeling changes and new postmarket study requirements for all extended-release and long-acting (ER/LA) opioid analgesics intended to treat pain.
Read more here…
September 7, 2013
The U.S. District Court for the District of Idaho entered a consent decree of permanent injunction against owner Gregory T. Troost, doing business as T&T Cattle and T&T Cattle Pearl, and manager Mark A. Mourton of Parma, Idaho for violations including illegally administering animal drugs for uses that are not approved by the U.S. Food […]
Read more here…