Medscape Medical News

Alert European Commission Greenlights Drug-Sparing Dovato for HIV Dovato (dolutegravir and lamivudine), a single-pill, two-drug regimen taken once daily, is noninferior to a three-drug regimen for treatment-naïve adults and children older than 12 with HIV in Europe.
News, July 2019
Alert Green Light for CVD Data From DECLARE in Dapagliflozin EU Label The EMA CHMP gives green light to change EU label for dapagliflozin (Forxiga, AstraZeneca) for type 2 diabetes to include CV outcomes data from DECLARE-TIMI 58.
News, July 2019
Alert EU Panel Backs Angiotensin II (Giapreza) for Septic Shock Giapreza is for refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines.
News, June 2019
Alert EU Panel Endorses Atezolizumab in PD-L1+, Metastatic TNBC The Committee for Medicinal Products for Human Use recommends approval of the immunotherapy as first-line treatment for triple-negative breast cancer (TNBC) patients with PD-L1+ disease.
News, June 2019
Alert CHMP Backs Generic Lacosamide UCB for Partial-Onset Seizures Lacosamide UCB, a generic version of Vimpat, is for partial-onset seizures with or without secondary generalization in adults and children as young as age 4 years with epilepsy.
News, June 2019
Alert EU OKs Liraglutide in Kids; Rejects Romosozumab for Osteoporosis The CHMP recommended approval of the GLP-1 agonist liraglutide for type 2 diabetes in children aged 10 and older, but it recommended refusal of marketing authorization for osteoporosis agent romosozumab.
News, June 2019
Alert Europe OKs PARP Inhibitor Talazoparib in BRCA+ Breast Cancer The new approval is for patients with germline BRCA-mutated, HER2 negative locally advanced or metastatic breast cancer.
News, June 2019
Alert European Commission OKs Dupilumab for Severe Asthma Dupilumab is for patients with moderate-to-severe asthma and increased blood eosinophil and/or raised fractional exhaled nitric oxide levels poorly controlled with other medicines.
News, May 2019
Alert European Commission Approves Risankizumab for Plaque Psoriasis In clinical studies, patients with moderate to severe plaque psoriasis saw significantly higher rates of skin clearance with risankizumab compared to current standards of care.
News, May 2019
Cemiplimab and Talazoparib Head Toward Approval in the EU Both drugs have received a positive opinion from the European Medicine Agency's Committee for Medicinal Products for Human Use, which is the first step in obtaining marketing approval in the European Union.
News, April 2019
Alert EMA Panel Recommends Nuceiva for Glabellar Lines A European Medicines Agency panel recommended marketing authorization for botulinum toxin type A (Nuceiva, Evolus Pharma Ltd) to temporarily correct glabellar lines in patients younger than 65 years.
News, April 2019
Alert EMA Panel Backs Triple Therapy Inhaler for COPD Temybric Ellipta combines fluticasone furoate, umeclidinium, and vilanterol in a single inhaler and is for maintenance treatment of moderate-to-severe COPD.
News, April 2019
Alert EU Panel Backs Dolutegravir/Lamivudine Combo Pill for HIV Dovato contains 50 mg dolutegravir and 300 mg lamivudine and would be the first once-daily, single-pill, completed 2-drug regimen for treatment of HIV in Europe.
News, April 2019
Alert EU Panel Recommends Hydroxycarbamide for Sickle Cell Disease An EMA committee recommended marketing authorization for hydroxycarbamide for the prevention of vaso-occlusive complications of sickle cell disease in patients older than 2 years.
News, April 2019
Alert EU Panel Backs Closer Sartan Monitoring, Generic PAH Drug The European Medicines Agency is taking further steps to prevent future nitrosamine impurities in blood pressure and diabetes meds, and recommended approval for another generic for PAH.
News, April 2019
Alert EC Approves Olaparib for BRCA Breast Cancer The European Commission has cleared olaparib (Lynparza, AstraZeneca/MSD) for the treatment of locally advanced or metastatic BRCA1/2 breast cancer.
News, April 2019
Alert EU Panel Backs First Gene Therapy for Beta Thalassemia Zynteglo is for patients 12 years and older who do not have a β0/β0 genotype, need regular blood transfusions to manage their disease, and have no matching donor for a stem cell transplant.
News, March 2019
Alert PCSK9 Alirocumab Picks Up New European Indication On the basis of ODYSSEY OUTCOMES results, alirocumab is now approved in Europe to reduce cardiovascular risk in adults with established disease.
News, March 2019
EU Panel Backs Dupilumab (Dupixent) for Moderate to Severe Asthma The CHMP recommends dupilumab for patients with moderate to severe asthma and increased blood eosinophil and/or raised fractional exhaled nitric oxide levels poorly controlled with other medications.
News, March 2019
EMA Panel Backs Zanamivir IV for Complicated, Severe Influenza The EMA's Committee for Medicinal Products for Human Use recommended marketing authorization under exceptional circumstances for zanamivir for complicated and potentially life-threatening influenza.
News, March 2019

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