Medscape Medical News

Alert EMA Recommends Upadacitinib for Rheumatoid Arthritis A European Medicines Agency advisory panel recommended marketing authorization for upadacitinib for the treatment of patients with rheumatoid arthritis.
News, October 2019
Alert EU Committee Backs Delafloxacin for ABSSSI A European Medicines Agency advisory panel recommended delafloxacin for acute bacterial skin and skin structure infections in adults when other commonly used antibacterial drugs are inappropriate.
News, October 2019
Alert EU Panel Gives Thumbs-Up on First Ebola Vaccine The V920 Ebola Zaire vaccine (Ervebo, Merck) protects against Ebola virus disease caused by Zaire Ebola virus in at-risk adults aged 18 years or older.
News, October 2019
Alert EU Panel Backs Drugs for Hypoglycemia, Osteoporosis After an initial no, CHMP backs romosozumab for severe osteoporosis with high fracture risk; Baqsimi is the first nasally administered treatment for severe hypoglycemia.
News, October 2019
Alert EMA Panel Endorses New Indications for Two Cancer Drugs The CHMP has recommended that two oncologic drugs be approved for additional uses in Europe.
News, October 2019
Alert EMA Panel Backs Esketamine Nasal Spray for Resistant Depression Spravato is for use with an oral antidepressant in adults with major depressive disorder who have failed at least two different antidepressants.
News, October 2019
Alert EU Panel: Don't Use Estradiol Creams for Longer Than 4 Weeks A European Medicines Agency committee warns against using certain estradiol creams for longer than a single period of 4 weeks to reduce the risk for adverse health effects.
News, October 2019
CHMP Supports Interferon-β During Pregnancy, Breastfeeding in MS The EMA committee advises updating the label of approved interferon-β products to allow use during pregnancy and breastfeeding in women with relapsing multiple sclerosis.
News, September 2019
Alert EMA Panel Backs Netarsudil for Elevated Intraocular Pressure An EMA advisory panel recommended marketing authorization for netarsudil ophthalmic solution 0.02% for the treatment of adults with glaucoma or ocular hypertension.
News, September 2019
Alert EMA Panel Backs Anesthetic Spray for Premature Ejaculation Senstend, a spray containing lidocaine/prilocaine, can improve ejaculatory control and sexual satisfaction and reduce distress related to ejaculation, the EMA said.
News, September 2019
Alert EMA Panel Backs Belimumab for Children With Lupus An EMA panel recommended extending the indication for belimumab to children aged 5 years and older with systemic lupus erythematosus.
News, September 2019
Alert EU Panel Votes to Expand Dulaglutide Indication Based on REWIND The panel also recommends approval of Qtrilmet, a fixed-dose combination of metformin hydrochloride/saxagliptin/dapagliflozin for treatment of type 2 diabetes.
News, September 2019
Alert New Option Soon for Some European Patients With Leukemia Gilteritinib has been recommended for approval for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) with an FLT3 mutation.
News, September 2019
Alert EC Clears Eculizumab (Soliris) for Neuromyelitis Optica Eculizumab is now indicated in Europe for adults with neuromyelitis optica spectrum disorder who are anti-aquaporin-4 (AQP4) antibody-positive and whose disease is following a relapsing course.
News, August 2019
Alert EMA Panel Recommends Ibalizumab for Multidrug-Resistant HIV-1 A European Medicines Agency advisory panel recommended marketing authorization for ibalizumab (Trogarzo, Theratechnologies International) for the treatment of patients with multidrug-resistant HIV-1 infection.
News, July 2019
Alert CHMP Backs Inhaled Levodopa (Inbrija) for Parkinson's 'Off' Episodes Levodopa inhalation powder is safe and effective in improving motor function during 'off' periods in patients with Parkinson's disease.
News, July 2019
Alert EMA Panel Backs Cannabis Drug for Severe Epilepsy CHMP gives thumbs up to GW Pharma's cannabidiol oral solution (Epidyolex) as an adjunctive treatment of Lennox-Gastaut syndrome and Dravet syndrome.
News, July 2019
Alert EU OK for First 'Histology-Independent' Cancer Drug The first so-called histology-independent cancer treatment has been recommended for approval in the European Union.
News, July 2019
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

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