http://feeds2.feedburner.com/emprnews Latest articles from MPR News News News custserv@haymarketmedia.com no Nuzyra, an aminomethylcycline (related to tetracycline antibiotics), is designed to overcome tetracycline resistance and has broad-spectrum activity against Gram-positive, Gram-negative and atypical bacteria, and other drug-resistant strains. https://www.empr.com/nuzyra-omadacycline-intravenous-tablet-for-pneumonia-skin-infections-available/article/832278/ Wed, 06 Feb 2019 14:00:00 GMT Nuzyra, an aminomethylcycline (related to tetracycline antibiotics), is designed to overcome tetracycline resistance and has broad-spectrum activity against Gram-positive, Gram-negative and atypical bacteria, and other drug-resistant strains. https://www.empr.com/nuzyra-omadacycline-intravenous-tablet-for-pneumonia-skin-infections-available/article/832278/ The NDA is supported by data from the Phase 3 ENLIVEN study (N=120) which randomized patients with symptomatic TGCT to receive pexidartinib or placebo to evaluate the safety and efficacy of the treatment. https://www.empr.com/pexidartinib-new-drug-application-accepted-for-tenosynovial-giant-cell-tumors/article/832070/ Wed, 06 Feb 2019 13:00:00 GMT The NDA is supported by data from the Phase 3 ENLIVEN study (N=120) which randomized patients with symptomatic TGCT to receive pexidartinib or placebo to evaluate the safety and efficacy of the treatment. https://www.empr.com/pexidartinib-new-drug-application-accepted-for-tenosynovial-giant-cell-tumors/article/832070/ Alyq should not be used with concomitant organic nitrates or guanylate cyclase (GC) stimulators (eg, riociguat), and in patients with a known serious hypersensitivity to tadalafil. https://www.empr.com/teva-alyq-tablets-generic-adcirca-for-pulmonary-arterial-hypertension-available/article/832360/ Wed, 06 Feb 2019 12:30:00 GMT Alyq should not be used with concomitant organic nitrates or guanylate cyclase (GC) stimulators (eg, riociguat), and in patients with a known serious hypersensitivity to tadalafil. https://www.empr.com/teva-alyq-tablets-generic-adcirca-for-pulmonary-arterial-hypertension-available/article/832360/ To investigate the effectiveness of compounded creams in the treatment of chronic pain conditions, study authors performed a double-blind, randomized, parallel study comparing creams compounded with an active ingredient to placebo creams. https://www.empr.com/compounded-topical-pain-creams-for-chronic-pain-efficacy-evaluated/article/832051/ Tue, 05 Feb 2019 19:00:00 GMT To investigate the effectiveness of compounded creams in the treatment of chronic pain conditions, study authors performed a double-blind, randomized, parallel study comparing creams compounded with an active ingredient to placebo creams. https://www.empr.com/compounded-topical-pain-creams-for-chronic-pain-efficacy-evaluated/article/832051/ Both filings have been granted Priority Review by the Agency. https://www.empr.com/merck-antibacterial-drugs-nda-review-relebactam-urinary-abdominal-infections/article/832056/ Tue, 05 Feb 2019 17:00:00 GMT Both filings have been granted Priority Review by the Agency. https://www.empr.com/merck-antibacterial-drugs-nda-review-relebactam-urinary-abdominal-infections/article/832056/ In preclinical models, the inhibition of phosphorylated STAT3 (p-STAT3) by WP1066 resulted in the direct attack of various tumor cells. https://www.empr.com/glioblastoma-treatment-wp1066-orphan-drug-designation/article/832054/ Tue, 05 Feb 2019 14:56:33 GMT In preclinical models, the inhibition of phosphorylated STAT3 (p-STAT3) by WP1066 resulted in the direct attack of various tumor cells. https://www.empr.com/glioblastoma-treatment-wp1066-orphan-drug-designation/article/832054/ While the exact mechanism of action of cenobamate is not fully understood, it is believed to work through a dual mechanism. https://www.empr.com/new-drug-application-accepted-for-antiepileptic-treatment-cenobamate/article/831752/ Mon, 04 Feb 2019 19:00:00 GMT While the exact mechanism of action of cenobamate is not fully understood, it is believed to work through a dual mechanism. https://www.empr.com/new-drug-application-accepted-for-antiepileptic-treatment-cenobamate/article/831752/ It is designed to release fluocinolone acetonide, a corticosteroid, at an initial rate of 0.25mcg/day. https://www.empr.com/yutiq-fluocinolone-acetonide-intravitreal-implant-for-uveitis-available/article/831746/ Mon, 04 Feb 2019 16:30:00 GMT It is designed to release fluocinolone acetonide, a corticosteroid, at an initial rate of 0.25mcg/day. https://www.empr.com/yutiq-fluocinolone-acetonide-intravitreal-implant-for-uveitis-available/article/831746/ Baricitinib, a Janus kinase inhibitor, is currently approved under the brand name Olumiant for the treatment of moderately-to-severely active rheumatoid arthritis. https://www.empr.com/baricitinib-atopic-dermatitis-study-results-from-breeze-ad1-breeze-ad2/article/831745/ Mon, 04 Feb 2019 16:00:00 GMT Baricitinib, a Janus kinase inhibitor, is currently approved under the brand name Olumiant for the treatment of moderately-to-severely active rheumatoid arthritis. https://www.empr.com/baricitinib-atopic-dermatitis-study-results-from-breeze-ad1-breeze-ad2/article/831745/ Each DocuSol Kids mini-enema (5mL) contains a delivered dose of docusate sodium 100mg in a polyethylene glycol base. https://www.empr.com/docusol-kids-mini-enemas-for-general-constipation-in-children/article/831755/ Mon, 04 Feb 2019 15:38:46 GMT Each DocuSol Kids mini-enema (5mL) contains a delivered dose of docusate sodium 100mg in a polyethylene glycol base. https://www.empr.com/docusol-kids-mini-enemas-for-general-constipation-in-children/article/831755/ Alkermes plans to meet with the FDA to discuss next steps for ALKs 5461. https://www.empr.com/alks-5461-complete-response-letter-for-adjunctive-mdd-treatment/article/831721/ Mon, 04 Feb 2019 15:30:00 GMT Alkermes plans to meet with the FDA to discuss next steps for ALKs 5461. https://www.empr.com/alks-5461-complete-response-letter-for-adjunctive-mdd-treatment/article/831721/ Jeuveau, an aesthetic-only neurotoxin, was evaluated in 2 US Phase 3 placebo-controlled trials and a European and Canadian Phase 3 head-to-head trial vs onabotulinumtoxinA (Botox Cosmetic; Allergan). https://www.empr.com/jeuveau-prabotulinumtoxina-xvfs-for-injection-aesthetic-neurotoxin-approved/article/831722/ Mon, 04 Feb 2019 15:00:00 GMT Jeuveau, an aesthetic-only neurotoxin, was evaluated in 2 US Phase 3 placebo-controlled trials and a European and Canadian Phase 3 head-to-head trial vs onabotulinumtoxinA (Botox Cosmetic; Allergan). https://www.empr.com/jeuveau-prabotulinumtoxina-xvfs-for-injection-aesthetic-neurotoxin-approved/article/831722/ Levetiracetam Injection, an antiepileptic, is indicated as adjunct therapy in patients aged ≥16 years with partial onset seizures, myoclonic seizures in patients with juvenile myoclonic epilepsy, and primary generalized tonic-clonic seizures, when oral administration is temporarily not feasible. https://www.empr.com/dr-reddys-levetiracetam-in-054-sodium-chloride-injection-1500mg100ml-recall/article/831731/ Mon, 04 Feb 2019 14:30:00 GMT Levetiracetam Injection, an antiepileptic, is indicated as adjunct therapy in patients aged ≥16 years with partial onset seizures, myoclonic seizures in patients with juvenile myoclonic epilepsy, and primary generalized tonic-clonic seizures, when oral administration is temporarily not feasible. https://www.empr.com/dr-reddys-levetiracetam-in-054-sodium-chloride-injection-1500mg100ml-recall/article/831731/ Terrific Care/Medex Supply had purchased these test strips (which were distributed by Roche Diagnostics outside the country) from an unknown source, imported and sold them in the US. https://www.empr.com/inr-test-strip-recall-coaguchek-xs-pt-terrific-care-medex-supply/article/831622/ Fri, 01 Feb 2019 19:05:39 GMT Terrific Care/Medex Supply had purchased these test strips (which were distributed by Roche Diagnostics outside the country) from an unknown source, imported and sold them in the US. https://www.empr.com/inr-test-strip-recall-coaguchek-xs-pt-terrific-care-medex-supply/article/831622/ The patient, who had a history of anorexia nervosa-binge purge type, presented to the emergency department with severe abdominal pain, confusion, disorientation, and was experiencing visual hallucinations. https://www.empr.com/metformin-abuse-for-weight-loss-purposes-case-report/article/829667/ Fri, 01 Feb 2019 18:30:00 GMT The patient, who had a history of anorexia nervosa-binge purge type, presented to the emergency department with severe abdominal pain, confusion, disorientation, and was experiencing visual hallucinations. https://www.empr.com/metformin-abuse-for-weight-loss-purposes-case-report/article/829667/ Over 1400 clinical trials and research studies were reviewed by a panel of 13 experts to develop the new guideline. https://www.empr.com/2019-beers-criteria-for-inappropriate-medication-use-in-older-patients/article/831015/ Fri, 01 Feb 2019 18:00:00 GMT Over 1400 clinical trials and research studies were reviewed by a panel of 13 experts to develop the new guideline. https://www.empr.com/2019-beers-criteria-for-inappropriate-medication-use-in-older-patients/article/831015/ To investigate the association between this diabetes drug class and IBD risk, the study authors searched various databases for controlled clinical trials and observational studies involving DPP-4 inhibitors where IBD events were reported. https://www.empr.com/dipeptidyl-peptidase-4-dpp-4-inhibitors-inflammatory-bowel-disease-risk/article/830901/ Fri, 01 Feb 2019 17:30:00 GMT To investigate the association between this diabetes drug class and IBD risk, the study authors searched various databases for controlled clinical trials and observational studies involving DPP-4 inhibitors where IBD events were reported. https://www.empr.com/dipeptidyl-peptidase-4-dpp-4-inhibitors-inflammatory-bowel-disease-risk/article/830901/ After the approval of RZV for the prevention of herpes zoster in adults ≥50 years, the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) began monitoring the vaccine in the Vaccine Adverse Event Reporting System (VAERS). https://www.empr.com/shingrix-recombinant-zoster-vaccine-safety-surveillance-data-mmwr/article/830893/ Fri, 01 Feb 2019 17:30:00 GMT After the approval of RZV for the prevention of herpes zoster in adults ≥50 years, the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) began monitoring the vaccine in the Vaccine Adverse Event Reporting System (VAERS). https://www.empr.com/shingrix-recombinant-zoster-vaccine-safety-surveillance-data-mmwr/article/830893/ Research has shown that ≥95% of the 32 million people in the United States with a documented penicillin allergy are ultimately able to tolerate this class of medications. https://www.empr.com/penicillin-allergy-evaluation-drug-challenge-management-review/article/829683/ Thu, 31 Jan 2019 17:30:00 GMT Research has shown that ≥95% of the 32 million people in the United States with a documented penicillin allergy are ultimately able to tolerate this class of medications. https://www.empr.com/penicillin-allergy-evaluation-drug-challenge-management-review/article/829683/ Mylan plans to make Wixela Inhub available in 3 strengths: 100mcg/50mcg, 250mcg/50mcg, and 500mcg/50mcg. https://www.empr.com/mylan-wixela-inhub-advair-diskus-generic-approved/article/830604/ Thu, 31 Jan 2019 17:05:00 GMT Mylan plans to make Wixela Inhub available in 3 strengths: 100mcg/50mcg, 250mcg/50mcg, and 500mcg/50mcg. https://www.empr.com/mylan-wixela-inhub-advair-diskus-generic-approved/article/830604/ Currently, there are no approved therapies for the treatment of MSA, a rare progressive neurodegenerative disease. https://www.empr.com/prana-pbt434-for-multiple-system-atrophy-orphan-drug/article/830882/ Thu, 31 Jan 2019 16:30:00 GMT Currently, there are no approved therapies for the treatment of MSA, a rare progressive neurodegenerative disease. https://www.empr.com/prana-pbt434-for-multiple-system-atrophy-orphan-drug/article/830882/ In the Complete Response Letter (CRL), the FDA noted that it was unable to approve the application in its present form, however the Agency did not request additional clinical studies. https://www.empr.com/complete-response-letter-for-apomorphine-sublingual-film-for-parkinson-off-episodes/article/830697/ Thu, 31 Jan 2019 15:30:00 GMT In the Complete Response Letter (CRL), the FDA noted that it was unable to approve the application in its present form, however the Agency did not request additional clinical studies. https://www.empr.com/complete-response-letter-for-apomorphine-sublingual-film-for-parkinson-off-episodes/article/830697/ Crenezumab is an investigational monoclonal antibody that preferentially binds to and promotes the removal of neurotoxic oligomers, a form of beta-amyloid. https://www.empr.com/alzheimer-disease-investigational-treatment-crenezumab-studies-discontinued/article/830392/ Wed, 30 Jan 2019 18:00:00 GMT Crenezumab is an investigational monoclonal antibody that preferentially binds to and promotes the removal of neurotoxic oligomers, a form of beta-amyloid. https://www.empr.com/alzheimer-disease-investigational-treatment-crenezumab-studies-discontinued/article/830392/ Currently, the only drug approved by the Food and Drug Administration (FDA) for prophylaxis is erythromycin, a macrolide antibiotic. https://www.empr.com/gonococcal-ophthalmia-neonatorum-treatment-uspstf-final-recommendation-statement/article/830291/ Wed, 30 Jan 2019 17:30:00 GMT Currently, the only drug approved by the Food and Drug Administration (FDA) for prophylaxis is erythromycin, a macrolide antibiotic. https://www.empr.com/gonococcal-ophthalmia-neonatorum-treatment-uspstf-final-recommendation-statement/article/830291/ Previous Phase 2 studies confirmed esterol has minimal impact on liver cells and metabolic pathways, as well as on coagulation parameters. https://www.empr.com/estetrol-drospirenone-combined-oral-contraceptive-phase-3-trial-results/article/830396/ Wed, 30 Jan 2019 17:15:00 GMT Previous Phase 2 studies confirmed esterol has minimal impact on liver cells and metabolic pathways, as well as on coagulation parameters. https://www.empr.com/estetrol-drospirenone-combined-oral-contraceptive-phase-3-trial-results/article/830396/ Tolsura, which contains the azole antifungal itraconazole, is formulated using the Company's proprietary SUBA (SUper-BioAvailable) technology which improves the bioavailability of poorly soluble drugs. https://www.empr.com/systemic-fungal-infections-treatment-tolsura-available/article/830386/ Wed, 30 Jan 2019 17:05:00 GMT Tolsura, which contains the azole antifungal itraconazole, is formulated using the Company's proprietary SUBA (SUper-BioAvailable) technology which improves the bioavailability of poorly soluble drugs. https://www.empr.com/systemic-fungal-infections-treatment-tolsura-available/article/830386/ Phase 3 studies investigating safety, tolerability, and immunogenicity in both adults and children are currently underway. https://www.empr.com/pneumococcal-conjugate-vaccine-15-valent-breakthrough-therapy-designation/article/830388/ Wed, 30 Jan 2019 17:00:00 GMT Phase 3 studies investigating safety, tolerability, and immunogenicity in both adults and children are currently underway. https://www.empr.com/pneumococcal-conjugate-vaccine-15-valent-breakthrough-therapy-designation/article/830388/ Ibuprofen Oral Suspension is indicated for use as an analgesic and antipyretic. https://www.empr.com/infant-ibuprofen-recall-expanded-tris-pharma/article/830391/ Wed, 30 Jan 2019 16:30:00 GMT Ibuprofen Oral Suspension is indicated for use as an analgesic and antipyretic. https://www.empr.com/infant-ibuprofen-recall-expanded-tris-pharma/article/830391/ The blood-based in vitro test provides clinicians with initial screening information to determine the need for further diagnostic testing. https://www.empr.com/alzheimer-disease-brain-amyloidosis-blood-test-breakthrough-designation/article/830107/ Wed, 30 Jan 2019 16:00:00 GMT The blood-based in vitro test provides clinicians with initial screening information to determine the need for further diagnostic testing. https://www.empr.com/alzheimer-disease-brain-amyloidosis-blood-test-breakthrough-designation/article/830107/ The expanded approval was based on safety and efficacy data from a confirmatory Phase 3 randomized, double-blind, placebo-controlled multicenter study evaluating Osphena in patients with moderate to severe vaginal dryness. https://www.empr.com/osphena-vaginal-dryness-indication-approved/article/830090/ Tue, 29 Jan 2019 19:00:00 GMT The expanded approval was based on safety and efficacy data from a confirmatory Phase 3 randomized, double-blind, placebo-controlled multicenter study evaluating Osphena in patients with moderate to severe vaginal dryness. https://www.empr.com/osphena-vaginal-dryness-indication-approved/article/830090/ The procedure, known as Elevoplasty, was investigated in the S.I.L.E.N.C.E. study (Snoring Intervention via Elevoplasty in a Non-surgical Clinical Environment) which included 52 patients. https://www.empr.com/zelegent-elevo-device-fda-cleared-for-snoring-elevoplasty/article/830284/ Tue, 29 Jan 2019 18:30:00 GMT The procedure, known as Elevoplasty, was investigated in the S.I.L.E.N.C.E. study (Snoring Intervention via Elevoplasty in a Non-surgical Clinical Environment) which included 52 patients. https://www.empr.com/zelegent-elevo-device-fda-cleared-for-snoring-elevoplasty/article/830284/ Tanezumab is a humanized monoclonal antibody that selectively targets, binds to, and inhibits nerve growth factor (NGF). https://www.empr.com/tanezumab-second-phase-3-results-for-osteoarthritis-pain/article/830095/ Tue, 29 Jan 2019 18:00:00 GMT Tanezumab is a humanized monoclonal antibody that selectively targets, binds to, and inhibits nerve growth factor (NGF). https://www.empr.com/tanezumab-second-phase-3-results-for-osteoarthritis-pain/article/830095/ The TIDES trial is investigating the safety and efficacy of 2 doses of TAK-003 in preventing dengue fever caused by any of the 4 dengue virus serotypes. https://www.empr.com/tak-003-dengue-vaccine-candidate-preliminary-results-from-tides-trial/article/830093/ Tue, 29 Jan 2019 17:35:00 GMT The TIDES trial is investigating the safety and efficacy of 2 doses of TAK-003 in preventing dengue fever caused by any of the 4 dengue virus serotypes. https://www.empr.com/tak-003-dengue-vaccine-candidate-preliminary-results-from-tides-trial/article/830093/ This is currently the only liquid formulation of this agent available in the US. https://www.empr.com/leucovorin-calcium-injection-liquid-presentation-fresenius-kabi/article/830110/ Tue, 29 Jan 2019 17:30:00 GMT This is currently the only liquid formulation of this agent available in the US. https://www.empr.com/leucovorin-calcium-injection-liquid-presentation-fresenius-kabi/article/830110/ As a common hedgehog supplier has not yet been identified, the CDC is reminding pet owners to take proper precautions when handling these animals. https://www.empr.com/pet-hedgehogs-cause-of-multistate-outbreak-of-salmonella/article/830003/ Tue, 29 Jan 2019 14:00:00 GMT As a common hedgehog supplier has not yet been identified, the CDC is reminding pet owners to take proper precautions when handling these animals. https://www.empr.com/pet-hedgehogs-cause-of-multistate-outbreak-of-salmonella/article/830003/ In order to assess the safety of biologic agents in older patients, the authors utilized PubMed/Medline and Embase to search for studies conducted in older patients with inflammatory bowel disease, rheumatoid arthritis, or psoriasis. https://www.empr.com/elderly-treatment-with-biologic-therapy-increased-infection-risk/article/829387/ Mon, 28 Jan 2019 19:30:00 GMT In order to assess the safety of biologic agents in older patients, the authors utilized PubMed/Medline and Embase to search for studies conducted in older patients with inflammatory bowel disease, rheumatoid arthritis, or psoriasis. https://www.empr.com/elderly-treatment-with-biologic-therapy-increased-infection-risk/article/829387/ Tosymra is an intranasal spray containing sumatriptan 10mg, a selective 5-HT1B/1D receptor agonist. https://www.empr.com/tosymra-dfn-02-approved-by-fda-for-acute-migraines/article/829811/ Mon, 28 Jan 2019 18:30:00 GMT Tosymra is an intranasal spray containing sumatriptan 10mg, a selective 5-HT1B/1D receptor agonist. https://www.empr.com/tosymra-dfn-02-approved-by-fda-for-acute-migraines/article/829811/ In the ERASURE, FIXTURE, FEATURE, and JUNCTURE trials, psoriasis patients who reported problems in these quality of life measures (through the EQ-5D-3L questionnaire) were randomized to receive secukinumab 300mg or placebo and were assessed at weeks 4, 8, and 12. https://www.empr.com/cosentyx-quality-of-life-improvements-plaque-psoriasis-patients-pooled-data/article/830007/ Mon, 28 Jan 2019 17:30:00 GMT In the ERASURE, FIXTURE, FEATURE, and JUNCTURE trials, psoriasis patients who reported problems in these quality of life measures (through the EQ-5D-3L questionnaire) were randomized to receive secukinumab 300mg or placebo and were assessed at weeks 4, 8, and 12. https://www.empr.com/cosentyx-quality-of-life-improvements-plaque-psoriasis-patients-pooled-data/article/830007/ The approval was supported by data from the Phase 3 iLLUMINATE study (NCT02264574) in 212 adult patients. https://www.empr.com/imbruvica-plus-obinutuzumab-for-chronic-lymphocytic-leukemia-small-lymphocytic-lymphoma/article/829778/ Mon, 28 Jan 2019 17:05:00 GMT The approval was supported by data from the Phase 3 iLLUMINATE study (NCT02264574) in 212 adult patients. https://www.empr.com/imbruvica-plus-obinutuzumab-for-chronic-lymphocytic-leukemia-small-lymphocytic-lymphoma/article/829778/ In the summer of 2018, the FDA learned that some generic ARB medications, including valsartan, irbesartan, losartan and others contained nitrosamine impurities— including N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA)—posing a potential safety concern. https://www.empr.com/angiotensin-ii-receptor-blocker-impurities-fda-investigation/article/829495/ Fri, 25 Jan 2019 18:00:00 GMT In the summer of 2018, the FDA learned that some generic ARB medications, including valsartan, irbesartan, losartan and others contained nitrosamine impurities— including N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA)—posing a potential safety concern. https://www.empr.com/angiotensin-ii-receptor-blocker-impurities-fda-investigation/article/829495/ The study authors utilized a variety of search engines to obtain randomized and quasi-randomized trials assessing the efficacy of various medical interventions used in the treatment of traumatic hyphema following closed-globe trauma. https://www.empr.com/traumatic-hyphema-eye-bleeding-treatments-compared/article/829381/ Fri, 25 Jan 2019 17:30:00 GMT The study authors utilized a variety of search engines to obtain randomized and quasi-randomized trials assessing the efficacy of various medical interventions used in the treatment of traumatic hyphema following closed-globe trauma. https://www.empr.com/traumatic-hyphema-eye-bleeding-treatments-compared/article/829381/ Based on our finding, hydrochlorothiazide should be considered a possible offending agent when a patient presents with symptoms suspicious of drug induced lupus," the study authors concluded. https://www.empr.com/drug-induced-lupus-erythematosus-diagnosis-reached-by-exclusion-after-patient-reports-to-ed/article/829200/ Thu, 24 Jan 2019 17:15:57 GMT Based on our finding, hydrochlorothiazide should be considered a possible offending agent when a patient presents with symptoms suspicious of drug induced lupus," the study authors concluded. https://www.empr.com/drug-induced-lupus-erythematosus-diagnosis-reached-by-exclusion-after-patient-reports-to-ed/article/829200/ The Aptima assay is a nucleic acid amplification test designed for use in a clinical setting. https://www.empr.com/mycoplasma-genitalium-test-aptima-assay-sexually-transmitted-infection/article/829093/ Thu, 24 Jan 2019 17:05:00 GMT The Aptima assay is a nucleic acid amplification test designed for use in a clinical setting. https://www.empr.com/mycoplasma-genitalium-test-aptima-assay-sexually-transmitted-infection/article/829093/ The approval was based on findings from a Phase 4 safety and immunogenicity study that included ~2000 children. https://www.empr.com/fluzone-quadrivalent-05ml-dose-for-6-months-age-and-older/article/829085/ Thu, 24 Jan 2019 16:00:00 GMT The approval was based on findings from a Phase 4 safety and immunogenicity study that included ~2000 children. https://www.empr.com/fluzone-quadrivalent-05ml-dose-for-6-months-age-and-older/article/829085/ The uEXPLORER combines positron emission tomography (PET) with X-ray computed tomography (CT) allowing for imaging of the entire body at the same time. https://www.empr.com/united-imaging-healthcare-uexplorer-total-body-scanner-fda-approved/article/828565/ Thu, 24 Jan 2019 15:30:00 GMT The uEXPLORER combines positron emission tomography (PET) with X-ray computed tomography (CT) allowing for imaging of the entire body at the same time. https://www.empr.com/united-imaging-healthcare-uexplorer-total-body-scanner-fda-approved/article/828565/ The aim of the review was to assess the safety and efficacy of oral and parenteral iron for the treatment of RLS. https://www.empr.com/iron-therapy-for-restless-legs-syndrome-cochrane-review/article/826580/ Wed, 23 Jan 2019 19:00:00 GMT The aim of the review was to assess the safety and efficacy of oral and parenteral iron for the treatment of RLS. https://www.empr.com/iron-therapy-for-restless-legs-syndrome-cochrane-review/article/826580/ This investigational treatment was evaluated in 42 HS patients, of which 24 had previously failed anti-tumor necrosis factor (TNF) therapy. https://www.empr.com/hidradenitis-suppurativa-treatment-bermekimab-true-human-antibody-targeting-interleukin-1-alpha/article/828881/ Wed, 23 Jan 2019 17:30:00 GMT This investigational treatment was evaluated in 42 HS patients, of which 24 had previously failed anti-tumor necrosis factor (TNF) therapy. https://www.empr.com/hidradenitis-suppurativa-treatment-bermekimab-true-human-antibody-targeting-interleukin-1-alpha/article/828881/ Once-daily Pifeltro and Delstrigo were initially approved in August 2018 to treat HIV-1 infection in adults with no prior antiretroviral treatment experience. https://www.empr.com/pifeltro-delstrigo-supplemental-new-drug-application-switching-hiv-therapy/article/828879/ Wed, 23 Jan 2019 16:30:00 GMT Once-daily Pifeltro and Delstrigo were initially approved in August 2018 to treat HIV-1 infection in adults with no prior antiretroviral treatment experience. https://www.empr.com/pifeltro-delstrigo-supplemental-new-drug-application-switching-hiv-therapy/article/828879/ While more than 100 variants in the MUTYH gene have been linked with MUTYH-associated polyposis, the MUTYH-Associated Polyposis Genetic Health Risk report identifies the 2 most common genetic variants in people of Northern European ancestry. https://www.empr.com/23andme-genetic-risk-report-for-mutyh-associated-polyposis-colorectal-cancer/article/828748/ Wed, 23 Jan 2019 16:00:00 GMT While more than 100 variants in the MUTYH gene have been linked with MUTYH-associated polyposis, the MUTYH-Associated Polyposis Genetic Health Risk report identifies the 2 most common genetic variants in people of Northern European ancestry. https://www.empr.com/23andme-genetic-risk-report-for-mutyh-associated-polyposis-colorectal-cancer/article/828748/ TriVisc contains highly purified hyaluronic acid that helps supplement the viscous properties of the fluid in the knee joint. https://www.empr.com/osteoarthritis-knee-pain-trivisc-sodium-hyaluronate-available/article/828745/ Tue, 22 Jan 2019 20:30:00 GMT TriVisc contains highly purified hyaluronic acid that helps supplement the viscous properties of the fluid in the knee joint. https://www.empr.com/osteoarthritis-knee-pain-trivisc-sodium-hyaluronate-available/article/828745/