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Inrebic (fedratinib) capsules, new treatment for adult patients with certain types of myelofibrosis
22 August 2019
The U.S. Food and Drug Administration has approved Inrebic (fedratinib) capsules to treat adult patients with certain types of myelofibrosis. “Prior to today, there was one FDA-approved drug to treat patients with myelofibrosis, a rare bone marrow disorder. Our approval today provides another…
Pretomanid, new drug for the treatment of tuberculosis that affects the lungs
17 August 2019
The U.S. Food and Drug Administration has approved Pretomanid Tablets in combination with bedaquiline and linezolid for the treatment of a specific type of highly treatment-resistant tuberculosis (TB) of the lungs. “The threat of antimicrobial-resistant infections is a key challenge we face as a…
Baqsimi nasal powder ( glucagon), first treatment for severe hypoglycemia that can be administered without an injection
15 August 2019
The U.S. Food and Drug Administration has approved Baqsimi nasal powder, the first glucagon therapy approved for the emergency treatment of severe hypoglycemia that can be administered without an injection. Severe hypoglycemia occurs when a patient’s blood sugar levels fall to a level where he or…
Vitrakvi (larotrectinib), first ‘histology-independent’ treatment for solid tumours with a specific gene mutation
9 August 2019
EMA’s human medicines committee has recommended granting a marketing authorisation in the European Union for Vitrakvi (larotrectinib) for the treatment of adult and paediatric patients with solid tumours that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion. Treatment with…
Victoza, liraglutide, new treatment for children with type 2 diabetes
17 July 2019
EMA’s human medicines committee has recommended granting an extension of indication to Victoza (liraglutide) to include the treatment of children and adolescents aged 10 years or older with type 2 diabetes. This medicine is already approved for use together with diet and exercise in adults with…
Dupixent (dupilumab), first treatment for chronic rhinosinusitis with nasal polyps
16 July 2019
The U.S. Food and Drug Administration has approved Dupixent (dupilumab) to treat adults with nasal polyps (growths on the inner lining of the sinuses) accompanied by chronic rhinosinusitis (prolonged inflammation of the sinuses and nasal cavity). This is the first treatment approved for…
FDA approves Soliris (eculizumab), first treatment for neuromyelitis optica spectrum disorder, a rare autoimmune disease of the central nervous system
10 July 2019
The U.S. Food and Drug Administration has approved Soliris (eculizumab) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who areanti-aquaporin-4 (AQP4) antibody positive. NMOSD is an autoimmune disease of the central nervous system…
FDA approves Xpovio (selinexor), new treatment for refractory multiple myeloma
10 July 2019
The FDA has granted accelerated approval to Xpovio (selinexor) tablets in combination with the corticosteroid dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is resistant to several…
Piqray (alpelisib), first PI3K inhibitor for breast cancer
31 May 2019
The U.S. Food and Drug Administration approved Piqray (alpelisib) tablets, to be used in combination with the FDA-approved endocrine therapy fulvestrant, to treat postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative,…