Medscape Medical News

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
Alert CHMP Backs Oral Siponimod (Mayzent) for Multiple Sclerosis The European Medicines Agency panel recommends siponimod for the treatment of adults with secondary progressive MS with active disease evidenced by relapses or imaging features of inflammatory activity.
News, November 15, 2019
Alert EMA Panel Backs Solriamfetol (Sunosi) for Narcolepsy, OSA The dual-acting dopamine and norepinephrine reuptake inhibitor showed durable effects in reducing excessive sleepiness in patients with narcolepsy or obstructive sleep apnea (OSA).
News, November 15, 2019
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 18, 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 18, 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 18, 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 18, 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 18, 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 18, 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 07, 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 23, 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 20, 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 20, 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 20, 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 20, 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 20, 2019

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