The U.S. Food and Drug Administration today warned five eye care providers to stop the misleading advertising and promotion of refractive lasers used in eye surgery procedures such as LASIK. The FDA found that the providers’ advertisements and promotional materials did not offer consumers adequate information about associated risks, as well as warnings and possible […]
The U.S. Food and Drug Administration today approved Signifor (pasireotide diaspartate) injection for the treatment of Cushing’s disease patients who cannot be helped through surgery.
The U.S. Food and Drug Administration today approved Iclusig (ponatinib) to treat adults with chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), two rare blood and bone marrow diseases.
The U.S. Food and Drug Administration today approved raxibacumab injection to treat inhalational anthrax, a form of the infectious disease caused by breathing in the spores of the bacterium Bacillus anthracis. Raxibacumab also is approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate.
The U.S. Food and Drug Administration today expanded the approved use of Zytiga (abiraterone acetate) to treat men with late-stage (metastatic) castration-resistant prostate cancer prior to receiving chemotherapy.
• The FDA is warning consumers not to feed their pets certain Nature’s Deli Chicken Jerky Dog Treats packaged and distributed by Kasel Associates Industries Inc. (Kasel) with a lot code of BESTBY061913DEN. The company has declined to perform a voluntary recall at this time.
The U.S. Food and Drug Administration announced today that it is part of the first public-private partnership to promote medical device regulatory science with a focus on speeding the development, assessment, and review of new medical devices.
The U.S. Food and Drug Administration today approved Cometriq (cabozantinib) to treat medullary thyroid cancer that has spread to other parts of the body (metastasized).
The U.S. Food and Drug Administration announced today the approval of Flucelvax, the first seasonal influenza vaccine licensed in the United States produced using cultured animal cells, instead of fertilized chicken eggs. Flucelvax is approved to prevent seasonal influenza in people ages 18 years and older.
A Minnesota company and its president have agreed to enter into a Consent Decree of Permanent Injunction sought by the U.S. Food and Drug Administration for unlawfully distributing unapproved new drugs and adulterated dietary supplements.
The U.S. Food and Drug Administration today approved the HeartWare Ventricular Assist System, a left ventricular assist device (LVAD), to support heart function and blood flow in patients with end-stage heart failure who are awaiting a heart transplant.
The U.S. Food and Drug Administration today approved the Zilver PTX Drug-Eluting Peripheral Stent (Zilver PTX Stent), the first drug-eluting stent indicated to re-open a particular artery in the thigh (femoropopliteal artery) when narrowed or blocked as a result of peripheral artery disease (PAD).
The U.S. Food and Drug Administration today approved Xeljanz (tofacitinib) to treat adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to, or who are intolerant of, methotrexate.
The U.S. Food and Drug Administration today issued a Warning Letter to The Avalon Effect Inc., a company based in Franklin, Tenn., for its marketing of a light therapy product that claims to cure or treat symptoms of fungal meningitis, methicillin-resistant Staphylococcus aureus (MRSA), concussions, Lyme disease, and other diseases.
The U.S. Food and Drug Administration today expanded the approved use of Xarelto (rivaroxaban) to include treating deep vein thrombosis (DVT) or pulmonary embolism (PE), and to reduce the risk of recurrent DVT and PE following initial treatment.
The U.S. Food and Drug Administration announced today that Ameridose, LLC, based in Westborough, Mass., is voluntarily recalling all of its unexpired products in circulation. Products from Ameridose can be identified by markings that indicate Ameridose by name or by its company logo. A complete list of all products subject to this recall can be […]
Today, the U.S. Food and Drug Administration released a copy of the FDA Form 483 issued to the New England Compounding Center (NECC). The FDA observed and has since confirmed contaminated products and listed a number of observations regarding conditions in the clean room at NECC’s Framingham, Mass. facility.
The U.S. Food and Drug Administration today approved Synribo (omacetaxine mepesuccinate) to treat adults with chronic myelogenous leukemia (CML), a blood and bone marrow disease.
Venus Pharmaceuticals International Inc., of Hauppauge, N.Y., and Bharat Kakumanu, its chief executive officer, have agreed to stop production and distribution of dietary supplements into U.S. commerce and recall and destroy affected product produced prior to January 2012, due to repeated violations of current good manufacturing practice (cGMP) regulations. In addition, the firm is prohibited […]