FDA approves first treatment for rare blood disease
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The U.S. Food and Drug Administration today approved Elzonris (tagraxofusp-erzs) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients, two years of age and older.
FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs
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Today, the U.S. Food and Drug Administration cleared a mobile medical application (app) to help increase retention (the amount of time a patient participates) in an outpatient treatment program for individuals with opioid use disorder (OUD). The reSET-O app is a prescription cognitive behavioral therapy intended to be used in addition to outpatient treatment under the care of a health care professional,
FDA approves first treatment for Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder
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The U.S. Food and Drug Administration today approved Firdapse (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. LEMS is a rare autoimmune disorder that affects the connection between nerves and muscles and causes weakness and other symptoms in affected patients. This is the first FDA approval of a treatment for LEMS.
FDA approves new treatment for patients with acute myeloid leukemia
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The U.S. Food and Drug Administration today approved Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are 75 years of age or older or who have other chronic health conditions or diseases (comorbidities) that may preclude the use of intensive chemotherapy.
FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot
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The U.S. Food and Drug Administration expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL). This is the first FDA approval for treatment of newly diagnosed PTCL, and the agency used a new review program to complete the approval more quickly.
FDA highlights record-breaking number of generic drug approvals in October
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Today, the U.S. Food and Drug Administration is providing a summary of the generic drug approval actions for the month of October 2018 as part of its efforts to improve patient access to high-quality, lower cost, safe and effective medicines. In October, the FDA approved 110 generic drugs and tentatively approved 18 generic drugs, for a total of 128 approval actions.
FDA approves new drug to treat influenza
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The U.S. Food and Drug Administration approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza (flu) in patients 12 years of age and older who have been symptomatic for no more than 48 hours.
More Pharma News ...
- FDA launches global operation to crack down on websites selling illegal, potentially dangerous drugs
- FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old
- FDA approves first treatment for advanced form of the second most common skin cancer
- FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases
- FDA approves new kind of treatment for hairy cell leukemia
- FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease
- FDA approves treatment for two rare types of non-Hodgkin lymphoma