FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment
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The U.S. Food and Drug Administration today approved Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Neulasta (pegfilgrastim) to decrease the chance of infection as suggested by febrile neutropenia (fever, often with other signs of infection, associated with an abnormally low number of infection-fighting white blood cells), in patients with non-myeloid (non-bone marrow) cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia.
FDA takes new steps to advance digital health, opening docket to solicit feedback on software products
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Today, the FDA is opening a docket to solicit feedback on important provisions of the 21st Century Cures Act ("Cures Act"). The Cures Act amended the Federal Food, Drug, and Cosmetic Act to exclude certain medical software functions from the definition of a medical device. Under the Cures Act, Congress excluded specific types of software from FDA regulation, including general wellness software products, electronic patient records and more.
FDA approves novel preventive treatment for migraine
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The U.S. Food and Drug Administration today approved Aimovig (erenumab-aooe) for the preventive treatment of migraine in adults. The treatment is given by once-monthly self-injections. Aimovig is the first FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide, a molecule that is involved in migraine attacks.
FDA approves first epoetin alfa biosimilar for the treatment of anemia
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The U.S. Food and Drug Administration today approved Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. Retacrit is also approved for use before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss during surgery.
FDA expands approval of Gilenya to treat multiple sclerosis in pediatric patients
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The U.S. Food and Drug Administration today approved Gilenya (fingolimod) to treat relapsing multiple sclerosis (MS) in children and adolescents age 10 years and older. This is the first FDA approval of a drug to treat MS in pediatric patients.
FDA approves first therapy for rare inherited form of rickets, x-linked hypophosphatemia
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The U.S. Food and Drug Administration has approved Crysvita (burosumab-twza), the first drug approved to treat adults and children ages 1 year and older with x-linked hypophosphatemia (XLH), a rare, inherited form of rickets. XLH causes low levels of phosphorus in the blood. It leads to impaired bone growth and development in children and adolescents and problems with bone mineralization throughout a patient's life.
FDA permits marketing of artificial intelligence-based device to detect certain diabetes-related eye problems
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The U.S. Food and Drug Administration today permitted marketing of the first medical device to use artificial intelligence to detect greater than a mild level of the eye disease diabetic retinopathy in adults who have diabetes. Diabetic retinopathy occurs when high levels of blood sugar lead to damage in the blood vessels of the retina, the light-sensitive tissue in the back of the eye.
More Pharma News ...
- FDA approves new treatment for certain digestive tract cancers
- FDA approves first treatment for breast cancer with a certain inherited genetic mutation
- FDA updates the label of Tasigna to reflect that certain patients with a type of leukemia may be eligible to stop treatment after sustained response
- FDA approves novel gene therapy to treat patients with a rare form of inherited vision loss
- FDA launches new tool for sharing information that allows doctors to better manage antibiotic use; improve patient care
- FDA launches public education campaign to encourage adult smokers trying to quit cigarettes
- FDA approves first biosimilar for the treatment of certain breast and stomach cancers