Medscape Medical News

Alert EU Panel Backs Triple Combo Asthma Inhaler With Digital Sensor Enerzair Breezhaler combines indacaterol, glycopyrronium, and mometasone and comes with an optional digital sensor that collects data on patient use to support adherence.
News, May 06, 2020
Alert Sanofi's Biosimilar Insulin Aspart Gets Green Light in EU Biosimilar of fast-acting mealtime insulin aspart is given positive opinion by CHMP.
News, May 05, 2020
Alert EU Panel OKs Glasdegib for AML and Luspatercept for MDS Glasdegib has been recommended for approval in Europe for acute myeloid leukemia, and luspatercept has been recommended for anemia associated with myelodysplastic syndromes.
News, May 01, 2020
EMA Panel Backs Pretomanid for Drug-Resistant TB Pretomanid FGK, in combination with bedaquiline and linezolid, is for adults with extensively drug-resistant, treatment-intolerant, or nonresponsive multidrug-resistant tuberculosis.
News, March 31, 2020
Alert EMA Backs Fluad Tetra for Influenza Prophylaxis in the Elderly Fluad Tetra induces an immune response similar to that of the adjuvanted trivalent vaccine, with the added benefit of potentially protecting against both circulating type B viruses, the EMA said.
News, March 31, 2020
Alert EMA Panel Backs Zolgensma Gene Therapy for SMA Zolgensma is a gene therapy that addresses the genetic root cause of spinal muscular atrophy by replacing the defective or missing SMN1 gene to halt disease progression.
News, March 27, 2020
Alert EMA Panel Backs Two Antibacterials The EMA panel recommended approval of cefiderocol for infections due to aerobic Gram-negative organisms and of a generic of tigecycline for complicated skin, soft tissue, and intraabdominal infections.
News, March 02, 2020
Alert New Device for Intracranial Aneurysm Approved in Europe Cerus Endovascular has announced that it has received European CE Mark approval for its lead product, the Contour Neurovascular System, for the treatment of intracranial aneurysms.
News, February 18, 2020
Alert EMA Panel Backs First Treatment for Acute Hepatic Porphyria The European Medicines Agency's Committee for Medicinal Products for Human Use recommended marketing authorization for the first treatment for acute hepatic porphyria.
News, January 31, 2020
Alert EU Panel Backs Cholera Vaccine Vaxchora for Adults, Children The European Medicines Agency's Committee for Medicinal Products for Human Use recommended marketing authorization for Vaxchora recombinant, live, oral cholera vaccine.
News, January 31, 2020
Alert EMA Panel Backs Budesonide/Formoterol Hybrid for Asthma, COPD The CHMP has endorsed the hybrid medicine Budesonide/Formoterol Teva Pharma B.V., a duplicate of DuoResp Spiromax, for adults with asthma and chronic obstructive pulmonary disease.
News, January 31, 2020
Alert EMA Panel Backs Bempedoic Acid Alone and With Ezetimibe The CHMP has recommended approval of bempedoic acid (Nilemdo) and the combination of bempedoic acid/ezetimibe (Nustendi) for primary hypercholesterolemia and mixed dyslipidemia.
News, January 31, 2020
Alert EMA Panel Backs Crisaborole (Staquis) for Atopic Dermatitis The CHMP has recommended approval of the PDE-4 inhibitor for mild to moderate atopic dermatitis in adults and children as young as 2 years.
News, January 31, 2020
Alert Darolutamide (Nubeqa) Gets OK in Europe for Prostate Cancer It joins two other androgen receptor inhibitors for use in the treatment of nonmetastatic castration-resistant prostate cancer.
News, January 31, 2020
Alert First Approval for Fast-Acting Lispro for Diabetes; EU OKs Oral Semaglutide EMA panel recommends approval of oral GLP-1 agonist semaglutide for type 2 diabetes. It has also given the thumbs up to a mealtime, or fast-acting form, of insulin lispro for adults with diabetes.
News, January 31, 2020
Alert EMA Panel Backs Adalimumab Biosimilar Amsparity The CHMP has recommended approval of Pfizer's adalimumab biosimilar (Amsparity) for treatment of certain inflammatory and autoimmune disorders in adults and children.
News, December 16, 2019
Alert EMA Panel Endorses Antibacterial Drug Trio Recarbrio Recarbrio combines imipenem, cilastatin, and relebactam and is for the treatment of infections due to aerobic Gram-negative pathogens in adults with limited treatment options.
News, December 16, 2019
Alert Brolucizumab Gets EU Panel Backing for Wet AMD The treatment, previously approved by the FDA, offers less-frequent injections, and efficacy proven in two head-to-head global trials.
News, December 13, 2019
Alert EMA Panel Backs Fostamatinib (Tavalisse) for Chronic ITP Fostamatinib, a spleen tyrosine kinase inhibitor, helps increase and maintain the platelet count and reduce bleeding risk in adults with chronic immune thrombocytopenia refractory to other treatments.
News, November 15, 2019
Alert First Approval for Osilodrostat for Cushing Syndrome, in EU Move marks the first worldwide approval for cortisol synthesis inhibitor that normalizes cortisol levels in most patients with Cushing syndrome.
News, November 15, 2019

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