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MPR provides daily drug news and industry-supported drug information & education. Download our drug reference and clinical tools app today!
New York
Joined August 2008
Episodic migraine treatment now available for pediatrics.
empr.com
The sBLA for the pediatric indication is supported by data from the randomized, double-blind, placebo-controlled, phase 3 SPACE trial.
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A wearable, noninvasive device that evaluate cardiac timing intervals such as left ventricular ejection time, is given green light.
empr.com
The wearable, noninvasive CardioTag is designed to capture electrocardiogram, photoplethysmogram, and seismocardiogram signals, as well as heart rate and pulse rate.
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AbbVie's Rinvoq shows promise in treating severe alopecia.
empr.com
The UP-AA clinical program includes 2 studies assessing the safety and efficacy of upadacitinib in adults and adolescent patients with severe alopecia areata.
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New treatment approved for rare kidney diseases.
empr.com
Pegcetacoplan inhibits C3 activation by binding to C3 and its activation fragment C3b, thereby reducing C3 glomerular fragment deposition in patients with C3G and primary IC-MPGN.
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The review period for a potentially new treatment for hot flashes has been given an extension of 90 days by the FDA.
empr.com
Elinzanetant is a dual neurokinin-1,3 (NK-1,3) receptor antagonist.
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Doptelet approved for thrombocytopenia in pediatric patients with persistent or chronic immune thrombocytopenia who have had an insufficient response to a prior therapy.
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The approval was based on data from the randomized, double-blind, placebo-controlled phase 3b AVA-PED-301 trial.
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Dr George Tidmarsh, who has led the development of 7 FDA-approved drugs and headed up several biopharma companies, has been appointed as the director of the Center for Drug Evaluation and Research.
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Tidmarsh's areas of expertise include pediatrics, pediatric oncology, and neonatology.
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An FDA panel voted 10 to 1 against approving Otsuka and Lundbeck's combo treatment for PTSD.
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Brexpiprazole is an atypical antipsychotic approved under the brand name Rexulti.
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