Istituzioni

FDA approves system for the delivery of ear tubes under local anesthesia to treat ear infection

Food and Drug Administration - Lu, 25/11/2019 - 23:44
FDA has approved a new system, the Tubes Under Local Anesthesia (Tula) System, for the delivery of tympanostomy tubes, commonly referred to as ear tubes, that can be inserted into the eardrum to treat recurrent ear infections.
Categorie: Istituzioni

FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns

Food and Drug Administration - Lu, 25/11/2019 - 23:33
FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns
Categorie: Istituzioni

FDA approves new treatment for adults with partial-onset seizures

Food and Drug Administration - Gi, 21/11/2019 - 22:52
Today, the FDA approved a new treatment for adults with partial-onset seizures
Categorie: Istituzioni

FDA takes second action under international collaboration, approves new treatment option for patients with chronic lymphocytic leukemia

Food and Drug Administration - Gi, 21/11/2019 - 16:44
As part of Project Orbis, a collaboration with the Australian Therapeutic Goods Administration and Health Canada, the FDA granted supplemental approval to Calquence (acalabrutinib) for the treatment of adults with chronic lymphocytic leukemia or small lymphocytic lymphoma
Categorie: 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
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