Opdivo Qvantig. FDA has approved subcutaneous Nivolumab, an alternative to intravenous infusion

A form of Nivolumab that can be injected under the skin ( subcutaneous ) has gained approval from the Food ...

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Talazoparib, a PARP inhibitor, in combination with Enzalutamide, an ARPI, improves survival outcomes in metastatic castration resistant prostate cancer

Positive results from the phase 3 TALAPRO-2 study of Talazoparib ( Talzenna ), an oral poly ADP-ribose polymerase ( PARP ...

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Margenza based on Margetuximab for metastatic HER2-positive breast cancer. FDA has approved

The Food and Drug Administration ( FDA ) has approved Margetuximab-cmkb ( Margetuximab; Margenza ) in combination with chemotherapy, for ...

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FDA has approved Tecvayli for relapsed or refractory multiple myeloma

The Food and Drug Administration ( FDA ) has granted accelerated approval to Tecvayli ( Teclistamab-cqyv; Teclistamab ), the first ...

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Daprodustat in treatment of anaemia associated with chronic kidney disease

The treatment of anaemia associated with chronic kidney disease with Daprodustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor ( ...

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Blinatumomab has demonstrated significantly prolonged event-free survival compared with consolidation chemotherapy in pediatric patients with relapsed acute lymphoblastic leukemia

Data from a multicenter, randomized phase 3 study ( 20120215 ) evaluating the efficacy, safety and tolerability of Blinatumomab ( ...

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Benefits of maintenance Atezolizumab in extensive-stage small cell lung cancer: IMpower133

The latest analysis from the IMpower133 trial has demonstrated continued improvement in outcomes for patients with extensive-stage small cell lung ...

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Tomivosertib added on to continued checkpoint inhibitor therapy

Despite the broad activity of checkpoint inhibitors across tumor types, primary or secondary resistance after initial response represents a major ...

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PRESTO trial: nurse preferences between Lanreotide Autogel new syringe and Octreotide long-acting release current syringe in management of neuroendocrine tumors and acromegaly

PRESTO study has been presented at the 17th European Neuroendocrine Tumor Society ( ENETS ) Annual Conference. PRESTO was a multi-national, ...

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Expansion of Trulicity label to include results from REWIND cardiovascular and diabetes outcomes trial

The European Medicines Agency's Committee for Medicinal Products for Human Use ( CHMP ) issued a positive opinion recommending an ...

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Nintedanib in patients across a range of progressive fibrosing interstitial lung diseases

Progressive fibrosis of the lung can have a devastating impact on patients with a range of conditions. Except for idiopathic ...

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Hepatitis C drugs reduce liver-related deaths by nearly half

A new study from the UT Southwestern Simmons Comprehensive Cancer Center has demonstrated that antiviral drugs for hepatitis C reduce ...

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PRIMA trial: Niraparib has demonstrates significant improvement in progression free survival for women regardless of their biomarker status, with ovarian cancer in the first line maintenance setting

Positive results from PRIMA ( ENGOT-OV26/GOG-3012 ) were announced. PRIMA is a phase 3 randomized, double-blind, placebo-controlled, study of Niraparib ...

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Venetoclax as a chemotherapy-free combination regimen for previously untreated chronic lymphocytic leukemia patients

In April 2016, the U.S. FDA ( Food and Drug Administration ) first granted accelerated approval of Venclexta ( Venetoclax ...

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Belimumab on health-related quality of life and fatigue in patients with systemic lupus erythematosus: 6 years of treatment

A study has reported long-term health-related quality of life ( HRQoL ) and fatigue outcomes in patients with systemic lupus ...

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New therapies for multiple myeloma: Daratumumab, Elotuzumab, Ixazomib

At the 57th American Society of Hematology ( ASH ) Annual Meeting and Exposition in Orlando, investigators at Dana-Farber Cancer ...

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Vadadustat, a potentially novel approach to treat anemia related to chronic kidney disease in patients who are not dependent on dialysis

Data on Vadadustat ( AKB-6548 ) were presented at the 2014 European Renal Association - European Dialysis and Transplant Association ...

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CONNECT trial: cognitive performance in adult patients treated with Vortioxetine for major depressive disorder

The results from CONNECT, a new study that has evaluated the effect of Vortioxetine ( Brintellix ) 10-20 mg/d on ...

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Eravacycline for the treatment of complicated intra-abdominal infections and complicated urinary tract infections

The following key attributes of Rravacycline, observed in clinical trials and preclinical studies of Eravacycline, differentiate Eravacycline from other antibiotics ...

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Human proprotein convertase subtilisin/kexin type 9 monoclonal antibodies: safety and efficacy of Alirocumab 150 mg every 2 weeks

Alirocumab ( Praluent ), a fully human monoclonal antibody to proprotein convertase subtilisin/kexin type 9 [ PSCK9 ], is in ...

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CHMP has recommended Sjnjardy, a combination of Empagliflozin and Metformin HCL, for patients with type 2 diabetes mellitus

Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has recommended ...

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Pembrolizumab, an investigational anti-PD-1 immunotherapy, in previously-treated patients with non-small cell lung cancer

Interim data from a phase 1B trial ( PN001 ) evaluating Pembrolizumab ( MK-3475 ), an investigational anti-PD-1 immunotherapy, in ...

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Combination of HCV therapies Grazoprevir and Elbasvir: sustained virologic response at post-treatment follow-up week 12 seen in 100% of patients in two of the three combination arms studied

Interim data from the ongoing C-WORTHY study, a phase II clinical trial evaluating the efficacy and safety of an all-oral ...

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Female patients with acne and the triad of cutaneous hyperandrogenism: the efficacy of oral Isotretinoin versus Cyproterone

SAHA ( Seborrhea, Acne, Hirsutism and Androgenetic Alopecia ) syndrome is a dermatologic disorder, with variant response to treatment. Triad ...

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Serelaxin improves symptoms and mortality across multiple subgroups of patients with acute heart failure

Results from a new analysis of the phase III RELAX-AHF study published in the European Heart Journal and presented at ...

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Autoimmune thyroid diseases and vitamin D

Vitamin D deficiency ( levels lower than 20 ng/ml ) is becoming a global health problem, since it is increasingly ...

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Vitamin D supplementation decreases diffuse musculoskeletal pain

Several studies have shown that vitamin D supplementation could be useful for treating diffuse musculoskeletal ( DMS ) pain in ...

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Sirolimus / Tacrolimus more effective than Methotrexate / Tacrolimus in the prevention of grade II-IV acute GVHD and moderate-severe chronic GVHD

There is evidence suggesting that Sirolimus, in combination with Tacrolimus, is active in the prevention of graft-versus-host disease ( GVHD ...

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Patients with moderately to severely active ulcerative colitis: 4-year maintenance treatment with Humira

The safety and efficacy of Adalimumab ( Humira ) for patients with moderately to severely active ulcerative colitis has been ...

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Ceftaroline fosamil for the treatment of complicated skin and soft tissue infections or community acquired pneumonia

Ceftaroline fosamil ( Zinforo ) is a new intravenous cephalosporin antibiotic indicated for the treatment of adult patients with ...

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COPD: Tiotropium plus Olodaterol Respimat fixed-dose combination has shown lung function benefits

Boehringer Ingelheim has announced submission of Marketing Authorisation Applications in 31 European countries for the once-daily fixed-dose combination of Tiotropium ...

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FDA is investigating risk of cardiovascular events with Testosterone products

The FDA ( Food and Drug Administration ) is investigating the risk of stroke, myocardial infarction, and death in men ...

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Brintellix for the treatment of adults with major depressive episodes, approved by European Commission

The European Commission granted marketing authorization for Brintellix ( Vortioxetine ) for the treatment of adults with major depressive episodes. ...

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Tretten to treat congenital Factor XIII A-subunit deficiency, a rare genetic clotting disorder, FDA approved

The FDA ( Food and Drug Administration ) has approved Tretten, coagulation Factor XIII A-subunit ( recombinant ), the first ...

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CHMP positive opinion for Cimzia in active psoriatic arthritis

The European Medicines Agency’s ( EMA’s ) Committee for Medicinal Products for Human Use ( CHMP ) has adopted a ...

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Olysio, a new therapy to treat chronic hepatitis C virus infection, approved by FDA

Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or ...

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Nexavar to treat metastatic differentiated thyroid cancer, FDA approved

The FDA ( Food and Drug Administration ) has expanded the approved uses of Nexavar ( Sorafenib ) to treat ...

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Kadcyla for advanced HER2-positive breast cancer, approved in EU

Roche has announced that Kadcyla ( Trastuzumab emtansine or T-DM1 ) has been approved by the European Commission for people ...

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EU: Xofigo for adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases, approved

Bayer HealthCare has announced that the European Commission ( EC ) has granted marketing authorisation for Xofigo 1000 kBq/ml, solution ...

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Dipeptidyl peptidase-4 inhibitors may also reduce the risk of autoimmune diseases in patients with type 2 diabetes

Dipeptidyl peptidase-4 inhibitors commonly used to control blood sugar levels in people with type 2 diabetes may also reduce the ...

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FDA: safety labeling changes and postmarket study requirements for extended-release and long-acting opioid analgesics

The Food and Drug Administration ( FDA ) has announced class-wide safety labeling changes and new postmarket study requirements for ...

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Abraxane for metastatic pancreatic cancer, FDA approved

The Food and Drug Administration ( FDA ) has expanded the approved uses of Abraxane ( Paclitaxel protein-bound particles for ...

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Adempas to treat pulmonary hypertension, FDA approved

The Food and Drug Administration ( FDA ) has approved Adempas ( Riociguat ) to treat adults with two forms ...

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Multiple sclerosis: European Commission has approved Lemtrada

Genzyme has announced that the European Commission ( EC ) has granted marketing authorization for Lemtrada ( Alemtuzumab ). Lemtrada is ...

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Alzheimer's disease dementia: diuretics, sartans and ACE inhibitors have shown to decrease risk

A Johns Hopkins-led analysis of data previously gathered on more than 3,000 elderly Americans strongly suggests that taking certain blood ...

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Patients with heart failure: Digoxin linked to higher risk of mortality

Digoxin, a drug commonly used to treat heart conditions, was associated with a 72% higher rate of death among adults ...

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Perjeta for neoadjuvant breast cancer treatment, FDA approved

The FDA ( Food and Drug Administration ) has granted accelerated approval to Perjeta ( Pertuzumab ) as part of ...

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Kadcyla for the treatment of adult patients with HER2+, unresectable locally advanced or metastatic breast cancer

The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of ...

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Inflectra the first biosimilar monoclonal antibody to be approved in Europe

Hospira has announced the European Commission ( EC ) approval of Inflectra ( Infliximab ), Europe's first biosimilar monoclonal antibody ...

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Dabrafenib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation

The FDA ( Food and Drug Administration ) has approved Dabrafenib ( Tafinlar capsule ), for the treatment of patients ...

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Mirvaso for the facial erythema of rosacea, FDA approved

Galderma Laboratories has announced that the FDA ( Food and Drug Administration ) has approved Mirvaso ( Brimonidine ) topical ...

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FDA breakthrough therapy designation for Bimagrumab for sporadic inclusion body myositis

The FDA ( Food and Drug Administration ) has granted breakthrough therapy designation to Bimagrumab for sporadic inclusion body myositis ...

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Ruxolitinib in patients with refractory metastatic pancreatic cancer

Incyte has announced top-line results of the Phase II, randomized, double-blind, placebo-controlled RECAP trial of Ruxolitinib ( Jakafi ), its ...

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Xarelto for secondary prevention after an acute coronary syndrome, approved in European Union

Xarelto ( Rivaroxaban ), a novel oral anticoagulant, has been approved by the European Commission ( EC ) for the ...

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New indication for Eylea in EU: treatment of visual impairment due to macular edema secondary to central retinal vein occlusion

Bayer HealthCare has announced that Eylea ( Aflibercept solution for injection ) has been approved by the European Commission ( ...

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Treatment of metastatic colorectal cancer: Stivarga approved in the European Union

Bayer HealthCare has announced that the European Commission has approved Stivarga ( Regorafenib ) tablets for the treatment of adult ...

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European Commission has approved Aubagio for multiple sclerosis treatment

Sanofi and its subsidiary Genzyme have announced that the European Commission has granted marketing authorization for Aubagio ( Teriflunomide ) 14 ...

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GLYX-13 rapidly lifts depression without side effects

GLYX-13, a molecular cousin to Ketamine, induces similar antidepressant results without the street drug side effects, reported a study funded ...

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Risk of leukemia after cancer chemotherapy

While advancements in cancer treatment over the last several decades have improved patient survival rates for certain cancers, some patients ...

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Ibrutinib shows efficacy as treatment for chronic lymphocytic leukemia and mantle cell lymphoma

Two clinical studies published in the New England Journal of Medicine ( NEJM ) suggest that the novel agent Ibrutinib ...

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Radium-223 has reduced the risk of death by 30.5% in castration-resistant prostate cancer patients with symptomatic bone metastases and no known visceral metastatic disease

Bayer HealthCare has announced that the New England Journal of Medicine ( NEJM ) has published results from Phase III ...

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Minor or transient stroke: the combination of two anti-clotting drugs, Clopidogrel and Acetylsalicylic acid, reduces the risk of stroke

Results of a phase III clinical trial has shown that a simple drug regimen of two anti-clotting drugs, Clopidogrel ( ...

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Olmesartan Medoxomil can cause sprue-like enteropathy

FDA ( Food and Drug Administration ) has warned that the blood pressure drug Olmesartan Medoxomil ( marketed as Benicar, ...

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Synribo for chronic myelogenous leukemia, FDA approved

The FDA ( Food and Drug Administration ) has approved Synribo ( Omacetaxine mepesuccinate ) to treat adults with chronic ...

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High blood levels of Omega-3 fatty acids associated with increased risk of aggressive prostate cancer

A second large, prospective study by researchers at Fred Hutchinson Cancer Research Center ( Seattle; United States ) has confirmed ...

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Castration-resistant prostate cancer: significant overall survival benefit observed with Radium 223

Bayer HealthCare has announced that data from the pivotal Phase III ALSYMPCA ( ALpharadin in SYMptomatic Prostate CAncer ) trial ...

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Sorafenib has shown success in advanced differentiated thyroid cancer patients

The cancer drug Sorafenib ( Nexavar ) holds metastatic thyroid cancer at bay for nearly twice as long as a ...

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Patients with lung cancer who carry specific HER2 mutations may benefit from certain anti-HER2 drugs

New results from a retrospective study suggest that anti-HER2 treatments, like the widely used breast cancer agent Trastuzumab ( Herceptin ...

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Addition of Bevacizumab to initial treatment for glioblastoma does not improve patient overall survival or progression-free survival

Glioblastoma is the most common primary malignant brain tumor in adults and, despite treatment advances in recent years, the average ...

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Barrett's esophagus: Acetylsalicylic acid may fight cancer by slowing DNA damage

Aspirin ( Acetylsalicylic acid ) is known to lower risk for some cancers, and a new study led by a ...

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MGN1703, an immune-boosting colorectal cancer drug, shows promise

Final data from IMPACT study provide proof of principle for new treatment approach. The findings confirm the biological action of ...

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Metastatic or unresectable melanoma: FDA approves Tafinlar and Mekinist

The Food and Drug Administration ( FDA ) has approved two new drugs, Tafinlar ( Dabrafenib ) and Mekinist ( ...

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Giant cell tumor of the bone: FDA approves Xgeva

The Food and Drug Administration ( FDA ) has expanded the use of Xgeva ( Denosumab ) to treat adults ...

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SAVOR-TIMI-53 Cardiovascular Outcomes Trial: Onglyza does not effect on composite endpoint of cardiovascular death, non-fatal myocardial infarction or non-fatal ischaemic stroke

Bristol-Myers Squibb ( BMS ) and AstraZeneca have announced top line results of the phase 4 SAVOR-TIMI-53 ( Saxagliptin Assessment ...

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TRINOVA-1 trial: Trebananib in recurrent ovarian cancer study meets primary endpoint of progression-free survival

Amgen has announced that the Phase 3 TRINOVA-1 trial evaluating Trebananib plus Paclitaxel versus placebo plus Paclitaxel in recurrent ovarian ...

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RoActemra approved in European Union to treat children with juvenile idiopathic polyarthritis

Roche has announced that the European Medicines Agency ( EMA ) has approved RoActemra ( Tocilizumab ) to treat children ...

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Rheumatoid arthritis: fewer discontinuations due to adverse events, serious adverse events, serious infections in patients treated with Abatacept plus Methotrexate

Year 2 data has shown similar efficacy between Abatacept ( Orencia ) plus Methotrexate ( MTX ) and Adalimumab ( ...

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The long-term effects of Epratuzumab in systemic lupus erythematosus: no new safety or tolerability signals

New data from an open-label extension ( SL0008 ) of the EMBLEM phase 2b study evaluating the long-term effects of ...

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RAI-refractory differentiated thyroid cancer: Sorafenib shows significant improvement in progression-free survival

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals have announced positive data from the phase III DECISION trial investigating the use of ...

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Riociguat has demonstrated significant and sustained improvements in 6MWD and WHO functional class in patients with pulmonary arterial hypertension

Data from the interim analysis of the on-going PATENT-2 trial with Riociguat, the open-label long-term extension of the pivotal Phase ...

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Procysbi for management of nephropathic cystinosis : FDA approved

The Food and Drug Administration ( FDA ) has approved Procysbi ( Cysteamine bitartrate ) for the management of nephropathic ...

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Diclegis for pregnant women with nausea and vomiting: FDA approved

The FDA ( Food and Drug Administration ) has approved Diclegis ( Doxylamine and Pyridoxine ) to treat pregnant women ...

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Xofigo for advanced prostate cancer, FDA approved

The FDA ( Food and Drug Administration ) has approved Xofigo ( Radium Ra 223 dichloride ) to treat men ...

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ARISTOTLE subanalysis: efficacy of Apixaban in patients with non-valvular atrial fibrillation

Results from the subanalysis of the ARISTOTLE trial, published in Circulation, have shown that the reductions in stroke or systemic ...

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Inspra improves survival of stable patients with left ventricular systolic dysfunction

Eplerenone ( Inspra ) is a steroid nucleus-based mineralcorticoid receptor antagonist with a higher degree of selectivity than Spironolactone. ...

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Post-menopausal osteoporosis: Odanacatib, Cathepsin K inhibitor, increases BMD following prior Alendronate treatment

Merck, known as MSD outside the United States and Canada, has announced results from a phase II trial for Odanacatib, ...

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Positive CHMP opinion in EU for once-daily, oral Aubagio to treat relapsing-remitting multiple sclerosis

Genzyme, a Sanofi Company, has announced that the Committee for Medicinal Products for Human Use ( CHMP ) of the ...

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Rhabdomyolysis without the presence of neuroleptic malignant syndrome suspected of being associated with the use of Risperidone

Risperidone ( Risperdal ) is an atypical antipsychotic agent indicated for the treatment or management of schizophrenia, inappropriate behaviour associated ...

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Hepatotoxicity remains an important safety concern for all antiandrogen drugs

Antiandrogens are a class of drugs used in androgen deprivation therapy for the treatment of advanced or metastatic prostate cancer. ...

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Tecfidera as a first-line oral treatment for relapsing forms of multiple sclerosis

Biogen Idec has announced that the FDA ( Food and Drug Administration ) has approved Tecfidera ( Dimethylfumarate ), a ...

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Botulism antitoxin for use in neutralizing all seven known botulinum nerve toxin serotypes, approved by FDA

The FDA ( Food and Drug Administration ) has announced that it has approved Botulism Antitoxin Heptavalent ( A, B, ...

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Canagliflozin, a SGLT2 inhibitor, for the treatment of adults with type 2 diabetes

Janssen Pharmaceuticals has announced the FDA ( Food and Drug Administration ) has approved Invokana ( Canagliflozin ) for the ...

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HIV patients co-infected with hepatitis C virus: Faldaprevir combined with Pegylated Interferon and Ribavirin

Interim study results from STARTverso 4 presented at CROI have shown that 80% of hepatitis C ( HCV ) patients ...

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Telaprevir has shown efficacy among cirrhotic patients with genotype-1 chronic HCV compared to standard of care

Results from a sub-analysis of the REALIZE phase 3 study showed that Telaprevir, ( Incivo; Incivek ) in combination ...

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Hemacord: FDA has approved first cord blood product

The FDA ( Food and Drug Administration ) has approved Hemacord, the first licensed hematopoietic progenitor cells-cord ( HPC-C ) ...

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Enzyme replacement therapy with Elaprase for Hunter syndrome

Mucopolysaccharidosis II, also known as Hunter syndrome, is a rare, X-linked disease caused by a deficiency of the lysosomal enzyme ...

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Psoriasis: oral Apremilast achieves statistical significance for the primary endpoint of PASI-75 in the ESTEEM 1

The results from ESTEEM 1 for the treatment of psoriasis were presented at the American Academy of Dermatology annual meeting. ...

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Elotuzumab in patients with previously-treated multiple myeloma

Multiple myeloma is the second most common blood cancer and remains incurable despite advances in treatment options over the last ...

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Ultra long-acting beta-adrenoceptor agonist: Olodaterol for maintenance treatment of COPD, recommended for approval

Boehringer Ingelheim has announced that the FDA ( Food and Drug Administration ) Pulmonary-Allergy Drugs Advisory Committee ( PADAC ) ...

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Seebri Breezhaler as once-daily maintenance treatment for COPD in the European Union

European Commission ( EC ) has approved Seebri Breezhaler ( Glycopyrronium bromide ) 44 mcg delivered dose ( equivalent to ...

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