The U.S. Food and Drug Administration today approved Firazyr (icatibant) Injection for the treatment of acute attacks of a rare condition called hereditary angioedema (HAE) in people ages 18 years and older.
Category Archives: Drug Recalls & Safety Notices
FDA working with Mexico to protect safety of imported papayas
The U.S. Food and Drug Administration (FDA) and its counterpart agencies in the Mexican government, the National Service for Agroalimentary Public Health, Safety and Quality (SENASICA) and the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), are expanding their collaboration to reduce the risk of contamination of food that moves across the U.S.-Mexican border.
FDA requests seizure of adulterated seafood at California company
At the request of the U.S. Food and Drug Administration, U.S. Marshals, yesterday, seized seafood products manufactured by the Meiko Food Co., South El Monte, Calif., because the products are adulterated.
FDA hurricane preparedness checklist
The FDA reminds consumers to take precautions for storing water and ensuring the safety of their food and medical supplies for themselves and their pets during and after this week’s expected hurricane-related rain, possible flooding and power outages.
FDA approves Botox to treat specific form of urinary incontinence
The U.S. Food and Drug Administration today approved Botox (onabotulinumtoxinA) injection to treat urinary incontinence in people with neurologic conditions such as spinal cord injury and multiple sclerosis who have overactivity of the bladder.
FDA approves Adcetris to treat two types of lymphoma
The U.S. Food and Drug Administration today approved Adcetris (brentuximab vedotin) to treat Hodgkin lymphoma (HL) and a rare lymphoma known as systemic anaplastic large cell lymphoma (ALCL).
FDA approves Zelboraf and companion diagnostic test for late-stage skin cancer
The U.S. Food and Drug Administration today approved Zelboraf (vemurafenib), a drug to treat patients with late-stage (metastatic) or unresectable (cannot be removed by surgery) melanoma, the most dangerous type of skin cancer.
FDA: Regulatory science plan positions agency to foster innovation through better science
The U.S. Food and Drug Administration today released its “Strategic Plan for Regulatory Science,” calling for a sweeping modernization of the science used in developing and evaluating products critical to the nation’s health, economy, and security.
FDA proposes guidelines that clarify benefit-risk determinations for medical devices
For the first time, the U.S. Food and Drug Administration has provided draft guidance clarifying how benefit-risk determinations are made during premarket review of certain medical devices.
FDA seeks comment on proposed guidelines for high-quality clinical studies
The FDA today issued draft guidance to help researchers and manufacturers design better quality clinical studies in support of premarket approval (PMA) applications for medical devices.