FDA expands approval of replacement heart valve, smallest mechanical valve size approved in the world
FDA expands approval of replacement heart valve, smallest mechanical valve size approved in the world
Archive for the ‘Drug Recalls & Safety Notices’ category
FDA approves new HIV treatment for patients who have limited treatment options
The FDA approved Trogarzo (ibalizumab-uiyk), a new type of antiretroviral medication for adult patients living with HIV who have tried multiple HIV medications in the past (heavily treatment-experienced) and whose HIV infections cannot be successfully treated with other currently available therapies.
FDA authorizes, with special controls, direct-to-consumer test that reports three mutations in the BRCA breast cancer genes
FDA has authorized 23andMe to market a consumer test that reports only 3 out of more than 1,000 known mutations in BRCA genes
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s commitment to modernizing food and nutrition programs
FDA announces commitment to modernize and streamline our food and nutrition programs to make sure that our investments of new and existing resources achieve their intended public health goals.
FDA warns of fraudulent and unapproved flu products
FDA warns of fraudulent and unapproved flu products
FDA alerts health care professionals and patients not to use compounded drugs from Cantrell Drug Company; agency seeks action to stop production and distribution
FDA is alerting not to use drug products produced by Cantrell Drug Company that were distributed nationwide.
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new efforts to advance implementation of the new consumer Nutrition Facts label for foods
Americans rely on the U.S. Food and Drug Administration to ensure that food labels contain updated nutritional information to help them make more informed food choices that lead to better health for themselves and their families. I’ve made nutrition one of my top priorities, and ensuring that consumers have accurate and science-based information concerning the […]
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s ongoing efforts to help improve effectiveness of influenza vaccines
FDA provides update on flu vaccines during this severe flu season
Statement from Stephen Ostroff M.D., Deputy Commissioner for Foods and Veterinary Medicine, on National Toxicology Program draft report on Bisphenol A
FDA provides update on Clarity-BPA
FDA oversees destruction and recall of kratom products; and reiterates its concerns on risks associated with this opioid
FDA oversees destruction and recall of kratom products; and reiterates its concerns on risks associated with this opioid
FDA expands approval of Imfinzi to reduce the risk of non-small cell lung cancer progressing
FDA approves drug to reduce the risk of stage III non-small cell lung cancer progressing
Statement from FDA Commissioner Scott Gottlieb, M.D. on the efficacy of the 2017-2018 influenza vaccine
FDA provides update on flu vaccines during this severe flu season
FDA expands treatment window for use of clot retrieval devices in certain stroke patients
FDA expands treatment window for use of clot retrieval devices in certain stroke patient
Statement from FDA Commissioner Scott Gottlieb, M.D. on advancing the development of novel treatments for neurological conditions; part of broader effort on modernizing FDA’s new drug review programs
FDA’s 5 guidance documents provide details for drug development for neurological conditions such as ALS and Alzheimer’s disease
FDA approves new treatment for a certain type of prostate cancer using novel clinical trial endpoint
FDA approves Erleada (apalutamide), first treatment for non-metastatic, castration-resistant prostate cancer
FDA authorizes marketing of first blood test to aid in the evaluation of concussion in adults
FDA authorizes marketing of first blood test to aid in the evaluation of concussion in adults; new quick testing option to help reduce need for CT scans, radiation exposure for patients
FDA permits marketing of clinical decision support software for alerting providers of a potential stroke in patients
FDA permits marketing of clinical decision support software for alerting providers of a potential stroke in patients
Statement from FDA Commissioner Scott Gottlieb, M.D., on Administration’s request for new FDA funding to promote innovation and broaden patient access through competition
Statement from FDA Commissioner Scott Gottlieb, M.D., on Administration’s request for new FDA funding to promote innovation and broaden patient access through competition
Statement from FDA Commissioner Scott Gottlieb, M.D., on groundbreaking approval and interagency approach to bring stable supply of critical medical imaging isotope to the U.S.
FDA announces on groundbreaking approval and interagency approach to bring stable supply of critical medical imaging isotope to the U.S.