Istituzioni

FDA approves first targeted therapy to treat patients with painful complication of sickle cell disease

Food and Drug Administration - Me, 20/11/2019 - 21:38
Today the FDA approved Adakveo (crizanlizumab-tmca), a treatment to reduce the frequency of vaso-occlusive crisis – a common and painful complication of sickle cell disease that occurs when blood circulation is obstructed by sickled red blood cells – for patients age 16 years and older.
Categorie: Istituzioni

FDA approves first treatment for inherited rare disease

Food and Drug Administration - Me, 20/11/2019 - 18:25
: FDA grants approval to Givlaari (givosiran) for the treatment of adult patients with acute hepatic porphyria, a genetic disorder resulting in the buildup of toxic porphyrin molecules which are formed during the production of heme (which helps bind oxygen in the blood)
Categorie: Istituzioni

FDA approves first contact lens indicated to slow the progression of nearsightedness in children

Food and Drug Administration - Ve, 15/11/2019 - 23:07
FDA approved the first contact lens to slow the progression of myopia in children, which ultimately could mean a reduced risk of developing other eye problems. MiSight is a daily, disposable contact lens approved for children 8-12 at the start of treatment.
Categorie: Istituzioni

FDA issues warning letter to Dollar Tree stores for receiving potentially unsafe drugs

Food and Drug Administration - Ve, 15/11/2019 - 21:32
FDA issues warning letter to Dollar Tree stores for receiving potentially unsafe drugs
Categorie: Istituzioni

FDA clears first duodenoscope with disposable elevator piece, reducing the number of parts needing disinfection

Food and Drug Administration - Ve, 15/11/2019 - 20:03
The FDA today cleared the first duodenoscope with a sterile, disposable elevator component that will reduce the number of parts that need to be cleaned and disinfected (reprocessed) in between uses.
Categorie: Istituzioni

FDA approves new antibacterial drug to treat complicated urinary tract infections as part of ongoing efforts to address antimicrobial resistance

Food and Drug Administration - Gi, 14/11/2019 - 23:43
The FDA today approved Fetroja (cefiderocol), an antibacterial drug for treatment of patients with complicated urinary tract infections (cUTI), including kidney infections caused by susceptible Gram-negative microorganisms, who have limited or no alternative treatment options.
Categorie: Istituzioni

FDA approves therapy to treat patients with relapsed and refractory mantle cell lymphoma supported by clinical trial results showing high response rate of tumor shrinkage

Food and Drug Administration - Gi, 14/11/2019 - 21:20
FDA has granted accelerated approval to Brukinsa (zanubrutinib) capsules for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy.
Categorie: Istituzioni

FDA approves first therapy to treat patients with rare blood disorder

Food and Drug Administration - Ve, 08/11/2019 - 18:28
FDA grants approval to Reblozyl (luspatercept–aamt) for the treatment of anemia in adult patients with beta thalassemia who require regular red-blood cell transfusions.
Categorie: Istituzioni

Statement on the agency’s efforts to protect patients through postmarket drug safety surveillance practices

Food and Drug Administration - Me, 06/11/2019 - 21:24
Today, the FDA is issuing an update on efforts to protect patients through postmarket drug safety surveillance practices
Categorie: Istituzioni

FDA authorizes marketing of first next-generation sequencing test for detecting HIV-1 drug resistance mutations

Food and Drug Administration - Ma, 05/11/2019 - 20:32
Today, the FDA authorized marketing of a test to detect human immunodeficiency virus (HIV) Type-1 drug resistance mutations using next generation sequencing (NGS) technology. It is the first HIV drug resistance assay that uses NGS that the FDA has authorized for marketing in the U.S.
Categorie: Istituzioni

Statement on new testing results, including low levels of impurities in ranitidine drugs

Food and Drug Administration - Ve, 01/11/2019 - 20:49
Today, the FDA is issuing an update on new testing results, including low levels of impurities in ranitidine drugs
Categorie: Istituzioni

USDA, EPA and FDA announce partnership with the Food Waste Reduction Alliance

Food and Drug Administration - Me, 30/10/2019 - 19:06
New partnership with the Food Waste Reduction Alliance, the latest effort in the Winning on Reducing Food Waste Initiative launched by the three federal agencies in 2018.
Categorie: Istituzioni

Digital submission of adverse event reports for investigational new drug applications reflects FDA’s ongoing modernization efforts

Food and Drug Administration - Ma, 29/10/2019 - 21:33
FDA is taking steps towards requiring electronic submission of certain safety reports under an investigational new drug (IND) application into the FDA's Adverse Event Reporting System (FAERS).
Categorie: Istituzioni

Statement on FDA’s new report regarding root causes and potential solutions to drug shortages

Food and Drug Administration - Ma, 29/10/2019 - 15:45
Today, the FDA is issuing a report on causes and solutions to drug shortages
Categorie: Istituzioni

FDA, FTC warn company marketing unapproved cannabidiol products with unsubstantiated claims to treat teething and ear pain in infants, autism, ADHD, Parkinson’s and Alzheimer’s disease

Food and Drug Administration - Lu, 28/10/2019 - 18:21
The U.S. Food and Drug Administration and the Federal Trade Commission posted a joint warning letter to Rooted Apothecary LLC for illegally selling unapproved products containing cannabidiol with unsubstantiated claims.
Categorie: Istituzioni

FDA approves new add-on drug to treat off episodes in adults with Parkinson’s disease

Food and Drug Administration - Ve, 25/10/2019 - 19:55
FDA approves new add-on drug to treat off episodes in adults with Parkinson’s disease
Categorie: Istituzioni

FDA announces voluntary recall of Sandoz ranitidine capsules following detection of an impurity

Food and Drug Administration - Ve, 25/10/2019 - 19:46
The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of 14 lots of prescription ranitidine capsules distributed by Sandoz Inc.
Categorie: Istituzioni

Statement on concerns with medical device availability due to certain sterilization facility closures

Food and Drug Administration - Ve, 25/10/2019 - 17:30
In light of the possibility of continued ethylene oxide sterilization facility closures, FDA is again alerting the public to growing concerns about the future availability of sterile medical devices and impending medical device shortages.
Categorie: Istituzioni

Baby powder manufacturer voluntarily recalls products for asbestos

Food and Drug Administration - Ve, 25/10/2019 - 15:51
The FDA is alerting consumers of a voluntary recall by Johnson & Johnson of Johnson’s Baby Powder after FDA testing has found that a sample from one lot of the product contains chrysotile fibers, a type of asbestos.
Categorie: Istituzioni
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