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.
Category Archives: Drug Safety Information Podcasts
FDA approves Iclusig to treat two rare types of leukemia
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.
FDA approves raxibacumab to treat inhalational anthrax
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.
FDA expands Zytiga’s use for late-stage prostate cancer
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.
FDA warns consumers not to feed certain Nature’s Deli Chicken Jerky Dog Treats
• 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.
FDA announces public-private partnership to develop regulatory science that will speed patient access to new medical device technologies
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.
FDA approves Cometriq to treat rare type of thyroid cancer
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).
FDA approves first seasonal influenza vaccine manufactured using cell culture technology
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.
Federal judge approves consent decree with Minnesota drug and dietary supplement company
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.
FDA approves pump for heart failure patients awaiting heart transplant
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.