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Juvisync, first combination drug to treat type 2 diabetes and high cholesterol in one tablet

The FDA ( Food and Drug Administration ) has approved Juvisync ( Sitagliptin and Simvastatin ), a fixed-dose combination ( ...
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Selected risk information for Juvisync, a combination of Sitagliptin and Simvastatin

Juvisync, is an FDC ( fixed-dose combination ) of the two medications, Sitagliptin and Simvastatin). Sitagliptin and Simvastatin have been ...
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Sitagliptin is comparable to Glipizide in helping patients lower blood sugar

In a clinical trial of patients with inadequate glycemic control on diet, exercise and Metformin monotherapy greater than 1500 mg/day, ...
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Anemia drug: Omontys linked to serious and fatal hypersensitivity reactions

The FDA ( Food and Drug Administration ) is alerting health care providers and patients of a voluntary nationwide recall ...
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Zytiga for late-stage prostate cancer, FDA approves

The FDA ( Food and Drug Administration ) has approved Zytiga ( Abiraterone acetate ) in combination with Prednisone ( ...
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TRITON-TIMI 38 trial: Prasugrel versus Clopidogrel in patients with acute coronary syndrome

TRITON-TIMI 38 was a head-to-head study comparing Prasugrel ( 60-mg loading dose [LD], followed by a 10-mg once-daily maintenance dose ...
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Nulojix for preventing acute rejection in kidney transplant recipients

The FDA ( Food and Drug Administration ) has approved Nulojix ( Belatacept ) to prevent acute rejection in adult ...
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Hepatitis C infection: Telaprevir-based regimen acts faster and offers a stronger viral cure than standard treatment

Telaprevir ( Incivek ) provides a improvement in the treatment of the most common form of hepatitis C infection. A ...
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Afinitor for advanced breast cancer, FDA approved

The FDA ( Food and Drug Administration ) has approved Afinitor ( Everolimus ) for use in combination with Aromasin ...
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PAVES trial: Pegfilgrastim reduces the incidence of febrile neutropenia in patients with colorectal cancer receiving FOLFOX or FOLFIRI and Bevacizumab

PAVES ( Pegfilgrastim and Anti-VEGF Evaluation Study ) trial has evaluated Pegfilgrastim ( Neulasta ) in 845 patients receiving FOLFOX ...
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Peginterferon beta-1a in relapsing-remitting multiple sclerosis: positive results from ADVANCE trial

Biogen Idec released the primary efficacy analysis and safety data from its Phase 3 pivotal clinical trial, ADVANCE. Results support ...
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Treatment of diabetes in adults: Tresiba and Ryzodeg approved in European Union

Novo Nordisk announced that the European Commission has granted marketing authorisations for Tresiba ( Insulin degludec ) and Ryzodeg ( ...
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FDA has approved three Alogliptin-based therapies for type 2 diabetes: Nesina, Oseni and Kazano

Takeda Pharmaceuticals has announced that the FDA ( Food and Drug Administration ) has approved Nesina ( Alogliptin ) and ...
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DECISION Trial: Sorafenib improves progression-free survival in patients with radioactive iodine refractory differentiated thyroid cancer

Bayer HealthCare and Onyx Pharmaceuticals have announced that a phase III trial of Nexavar ( Sorafenib ) tablets in patients ...
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Gardasil, HPV vaccine, approved to prevent anal cancer in United States

The FDA ( Food and Drug Administration ) has approved the vaccine Gardasil for the prevention of anal cancer and ...
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FDA has approved new indication for Tasigna: newly diagnosed patients with Philadelphia chromosome positive chronic phase chronic myeloid leukemia

The FDA ( Food and Drug Administration ) has approved a new indication for Tasigna ( Nilotinib ) for the ...
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FDA has approved new indication for Eltrombopag: supportive care for patients with thrombocytopenia with chronic hepatitis C to allow the initiation and maintenance of Interferon-based therapy

GlaxoSmithKline ( GSK ) has announced today the Food and Drug Administration ( FDA ) has approved Promacta ( Eltrombopag ...
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Gliptins: risk of acute pancreatitis

There have been reports of acute pancreatitis associated with drugs in the dipeptidylpeptidase-4 ( DPP-4 ) inhibitor class of antidiabetic ...
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Agomelatine: risk of dose-related hepatotoxicity and liver failure

There have been several serious cases of hepatotoxicity reported with Agomelatine ( Valdoxan / Thymanax ), including six reports worldwide ...
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Pradaxa: Boehringer Ingelheim discontinues RE-ALIGN trial in patients with artificial heart valves

Boehringer Ingelheim has taken the voluntary decision to discontinue treatment with the oral anticoagulant Dabigatran etexilate ( Pradaxa ) in ...
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Crohn’s disease: Ustekinumab induces clinical response

Ustekinumab ( Stelara ), an antibody proven to treat the skin condition psoriasis, has now shown positive results in decreasing ...
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Eylea for the treatment of patients with neovascular age-related macular degeneration

In the United States, Eylea ( Aflibercept ) injection is indicated for the treatment of patients with neovascular ( wet ...
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GS-7977 plus Pegylated Interferon and Ribavirin in patients with genotype 1 hepatitis C: 12-week regimen

Gilead Sciences has announced interim data from a phase 2 trial ( ATOMIC ) examining a 12-week course of treatment ...
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Eylea for the treatment of wet age-related macular degeneration in Europe

Regeneron Pharmaceuticals has announced that Eylea ( Aflibercept ) injection has been approved by the European Commission for the treatment ...
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VIEW 1 and VIEW 2 trials of Aflibercept injection for the treatment of patients with neovascular ( wet ) age-related macular degeneration: one-year results

Regeneron has announced that detailed one-year results from the VIEW 1 and VIEW 2 phase 3 studies of Aflibercept ( ...
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Eliquis for prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, approved in European Union

The European Commission ( EU ) has approved Eliquis ( Apixaban ) for prevention of stroke and systemic embolism in ...
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DIA3010 trial: Canagliflozin reduces A1C levels when added to antihyperglycemic therapy in older patients with type 2 diabetes and inadequate glycemic control

In a Phase 3 study presented at the 48th European Association for the Study of Diabetes ( EASD ) Annual ...
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Tofacitinib, a JAK inhibitor: the first new oral DMARD for rheumatoid arthritis in more than 10 years

The FDA ( Food and Drug Administration ) has approved Xeljanz ( Tofacitinib citrate ) 5 mg twice daily for ...
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B-Long trial: positive results for ling-lasting recombinant Factor IX Fc fusion protein in hemophilia B

Biogen Idec and Swedish Orphan Biovitrum ( Sobi ) have announced positive results from B-LONG, a clinical study that evaluated ...
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Lyxumia for treatment of diabetes mellitus type 2

Lixisenatide is a potent and highly selective GLP-1 peptide agonist, for once-daily injectable dosing to treat type 2 diabetes. Sanofi, which ...
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Hepatitis C: Daclatasvir and GS-7977 have achieved sustained virologic response in 100% of genotype 1 and 91% of genotype 2 and 3 treatment-naïve patients in phase II study

Bristol-Myers Squibb ( BMS ) has announced interim results from a phase II open-label study of Daclatasvir, NS5A replication complex ...
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European Union: Votrient has received marketing authorisation in the treatment of certain advanced soft tissue sarcoma subtypes

European Commission has granted Votrient ( Pazopanib ) marketing authorisation for the treatment of patients with advanced soft tissue sarcoma ...
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European Union: Jentadueto has received approval for the treatment of adults with diabetes mellitus type 2

European Commission has granted marketing authorization to Jentadueto, which combines the DPP-4 inhibitor, Linagliptin and Metformin in a single tablet. ...
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FDA: a mesothelin-targeting antibody-drug conjugate has received orphan drug status for the treatment of mesothelioma

Bayer HealthCare has announced that its investigational anti-cancer agent BAY 94-9343, a mesothelin-targeting antibody-drug conjugate ( ADC ), has been ...
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FDA has approved Rituximab to treat Wegener’s granulomatosis and microscopic polyangiitis

The FDA ( Food and Drug Administration ) has approved Rituxan ( Rituximab; in Europe: MabThera ), in combination with ...
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Metastatic melanoma: FDA has approved Yervoy

The FDA ( Food and Drug Administration ) has approved Yervoy ( Ipilimumab ) to treat patients with lmetastatic melanoma, ...
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Fluzone influenza vaccine: VAERS reports of febrile seizures in children

The FDA ( Food and Drug Administration ) and CDC ( Centers for Disease Control and Prevention ) routinely monitor ...
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EU: refusal of the marketing authorisation for Elelyso because of the ten-year market exclusivity that had been granted for Vpriv

The Committee for Medicinal Products for Human Use ( CHMP ) has recommended the refusal of a marketing authorisation for ...
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NICE recommends Xarelto, the only oral single-drug therapy for the treatment of deep vein thrombosis and prevention of recurrent DVT and pulmonary embolism

Oral anticoagulant Xarelto ( Rivaroxaban ) has been recommended for National Health Service ( NHS ) use in Final Guidance ...
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Truvada for pre-exposure prophylaxis to reduce risk of acquiring HIV

Gilead Sciences has announced that the Antiviral Drugs Advisory Committee of the FDA ( Food and Drug Administration ) has ...
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Myrbetriq is the first beta-3 adrenergic agonist indicated for the treatment of overactive bladder

The FDA ( Food and Drug Administration ) has approved Myrbetriq ( Mirabegron ) extended-release tablets for the treatment of ...
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Abnormal heart rhythms may be associated with use of Zofran

The FDA ( Food and Drug Administration ) has informed the public of an ongoing safety review of the anti-nausea ...
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Type 2 diabetes mellitus: improvement in albuminuria with Linagliptin in patients at high risk of declining renal function

Boehringer Ingelheim and Eli Lilly and Company have announced results from a post-hoc analysis that showed Linagliptin ( U.S. as ...
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Major depressive disorder: FDA has approved Viibryd

The FDA ( Food and Drug Administration ) has approved Viibryd tablets ( Vilazodone hydrochloride ) to treat major depressive ...
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FDA has approved Erbitux to treat late-stage head and neck cancer

The FDA ( Food and Drug Administration ) has approved Erbitux ( Cetuximab ) for use with chemotherapy to treat ...
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Knee or hip replacement surgery: FDA has approved Xarelto to reduce risk of blood clots

The FDA ( Food and Drug Administration ) has approved Xarelto ( Rivaroxaban ) to reduce the risk of blood ...
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2008 - COPD: ongoing safety review of Tiotropium, marketed as Spiriva HandiHaler

FDA ( Food and Drug Administration ) stated that Boehringer Ingelheim, the maker of Spiriva HandiHaler ( Tiotropium bromide ), ...
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Corifact for treatment of congenital factor XIII deficiency

The FDA ( Food and Drug Administration ) has granted marketing approval for Corifact, Factor XIII Concentrate ( human ), ...
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Treatment for plague: FDA has approved Levaquin

The FDA ( Food and Drug Administration ) has approved Levaquin ( Levofloxacin ) to treat patients with plague, a ...
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FDA has approved Pradaxa to prevent stroke in patients with atrial fibrillation

The FDA ( Food and Drug Administration ) has approved Pradaxa capsules ( Dabigatran etexilate ) for the prevention of ...
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Primary biliary cirrhosis: Bezafibrate

The treatment of primary biliary cirrhosis is complicated. There are studies suggesting that Bezafibrate, alone or in combination with Ursodeoxycholic ...
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Interferons not useful in the secondary progressive multiple sclerosis

Although it remains unclear how either beta-1a or beta-1b interferons ( IFNs ) work in multiple sclerosis, these therapies have ...
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Gaucher disease type 1: Eliglustat has shown sustained or continued improvement in all endpoints at four-year follow-up

Four-year follow-up data from patients enrolled in the phase 2 clinical trial for its investigational oral therapy for Gaucher disease ...
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Lynch syndrome: Acetylsalicylic acid reduces colorectal cancer rates by around 60%

The CAPP2 ( Colorectal Adenoma/carcinoma Prevention Programme ) trial has shown a reduction in colorectal cancer incidence of over 60% ...
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Prasugrel versus Clopidogrel: non-fatal heart attacks occur less often in certain patients, but major bleeding events are more common

In order to better prevent blood clots, the drugs Clopidogrel ( Plavix ) or Prasugrel ( Efient, Effient ) can ...
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MHRA: the balance of risks and benefits of Reboxetine remains favourable

Reboxetine ( Davedax, Edronax ) is a selective noradrenaline reuptake inhibitor antidepressant. It has been licensed in the UK since ...
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Follicular lymphoma: vaccine increases disease-free survival

A lymphoma vaccine uniquely tailored for each patient extends disease-free survival by 14 months, with signs of an even better ...
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FDA: revised dose limitation for Simvastatin when taken with Amiodarone

The FDA ( Food and Drug Administration ) has informed the public that it has revised the dose limitation for ...
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Crizotinib targets chromosomal rearrangements involving the gene ALK in patients with non-small cell lung cancer

New data from a phase I trial of Crizotinib ( Xalkori ), a small-molecule drug that targets cancer-causing chromosomal rearrangements ...
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Saxagliptin added to Insulin significantly improves glycosylated hemoglobin levels in adults with type 2 diabetes compared to placebo added to Insulin

Results from an investigational phase 3b clinical study have shown that Onglyza ( Saxagliptin ) 5 mg added to Insulin ...
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European Commission has approved Brilique for the prevention of atherothrombotic events in patients with acute coronary syndromes

European Commission has granted marketing authorisation to Brilique ( Ticagrelor ) for the prevention of atherothrombotic events in adult patients ...
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Idebenone improves sight for patients with Leber's hereditary optic neuropathy

A clinical trial led by Newcastle University has shown that the drug, Idebenone ( Catena ), improves the vision and ...
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Eylea for neovascular age-related macular degeneration in older people: FDA approved

The FDA ( Food and Drug Administration ) has approved Eylea ( Aflibercept ) to treat patients with wet ( ...
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Probuphine's implant has demonstrated compelling efficacy in patients suffering from opioid addiction

Data from a phase 3 randomized, placebo-controlled clinical trial of Probuphine have been published in the Journal of the American ...
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Hepatic encephalopathy: FDA has approved new use of Xifaxan for patients with liver disease

The FDA ( Food and Drug Administration ) has approved the use of Xifaxan for reduction in the risk of ...
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Expression of dystrophin in Duchenne Muscular Dystrophy patients treated with Eteplirsen

AVI BioPharma, a developer of RNA-based therapeutics, has announced that data published in The Lancet from a Phase 1b/2 study ...
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Fasudil, a cardiovascular drug may offer new treatment for some difficult types of leukemia

Fasudil, a drug now prescribed for cardiovascular problems could become a new tool in physicians' arsenals to attack certain types ...
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Multiple sclerosis: Teriflunomide significantly reduces relapse rate, disability progression and disease activity

The pivotal phase III TEMSO study with investigational once-daily oral medication Teriflunomide ( Aubagio ) has been published in The ...
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Raltegravir in combination therapy has shown efficacy and tolerability in adults with HIV-1 regardless of gender or race

Results from the REALMRK clinical study have shown that after 48 weeks of treatment in an open-label, single-arm, observational study, ...
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Boceprevir: indications and usage for the treatment of chronic hepatitis C genotype 1 infection

Victrelis( Boceprevir ) has been approved by the FDA ( Food and Drug Administration ) for the treatment of chronic ...
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Voriconazole and Anidulafungin combination therapy versus Voriconazole alone in invasive aspergillosis

The results of an phase III clinical trial which compared the combination of Voriconazole ( Vfend ) and Anidulafungin ( ...
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FDA has approved Combivent Respimat inhalation spray for the treatment of patients with chronic obstructive pulmonary disease

The FDA ( Food and Drug Administration ) has approved Combivent Respimat, a new, propellant-free inhaler product that uses a ...
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Genotype 1 hepatitis C: BMS-790052 plus Peginterferon alfa and Ribavirin demonstrated up to 83% sustained virologic response 24 weeks post-treatment

The results of a Phase II clinical trial of 48 treatment-naive genotype 1 hepatitis C infected patients in which treatment ...
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Selumetinib in patients with KRAS-mutant non-small cell lung cancer

The results from a randomized Phase 2 placebo-controlled study comparing the efficacy of Selumetinib in combination with Docetaxel with Docetaxel ...
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Metabolic therapy for autoimmune diseases: N-Acetylglucosamine suppresses multiple sclerosis attacks

A Glucosamine-like dietary supplement suppresses the damaging autoimmune response seen in multiple sclerosis, according study. Michael Demetriou, Ani Grigorian and ...
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Oral contraceptives containing Drospirenone linked to higher risk of venous thromboembolism than oral contraceptives containing Levonorgestrel

A nested case-control study within the UK General Practice Research Database has examined the risk of non-fatal idiopathic venous thromboembolism ...
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Zoledronic acid and risk of kidney failure: new contraindication in patients with osteoporosis

The FDA ( Food and Drug Administration ) has notified healthcare professionals and patients of an update to the drug ...
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Dronedarone, a controversial antiarrhythmic agent, provides only modest efficacy and non clear safety benefits

In a rigorous new review of the antiarrhythmic drug Dronedarone ( Multaq ), researchers at the Cedars-Sinai Heart Institute concluded ...
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European Commission: Vibativ for treating adults with nosocomial pneumonia, including ventilator-associated pneumonia

European Commission has granted marketing authorization for Vibativ ( Telavancin hydrochloride ), following the Committee for Human Medicinal Products' positive ...
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Zytiga for treatment of metastatic castration-resistant prostate cancer in patients who have received prior chemotherapy containing Docetaxel

The FDA ( Food and Drug Administration ) has approved Zytiga ( Abiraterone acetate ), an oral, once-daily medication for ...
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Long-term use of nonaspirin anti-inflammatory drugs linked to renal cell carcinoma

Long-term use of nonaspirin anti-inflammatory drugs ( NSAIDs ) is associated with an increased risk of renal cell cancer ( ...
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TNF-alpha blockers: warnings about infection with Legionella and Listeria bacteria

The FDA ( Food and Drug Administration ) has informed healthcare professionals that the Boxed Warning for the entire class ...
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Vemurafenib in patients with previously untreated metastatic melanoma with the BRAFV600 mutation

Plexxikon has announced efficacy and safety data from the BRIM3 trial, a large, randomized, multicenter phase 3 clinical study of ...
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Rare diseases: Firazyr, a self-administered subcutaneous treatment for acute hereditary angioedema

The Food and Drug Administration ( FDA ) has granted marketing approval for Firazyr ( Icatibant injection ) for treatment ...
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FDA has approved orphan drug Zactima for advanced medullary thyroid cancer

AstraZeneca has announced that the FDA ( Food and Drug Administration ) has approved the orphan drug Vandetanib ( Zactima ...
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FDA approves Firazyr to treat acute attacks of hereditary angioedema

The FDA ( Food and Drug Administration ) has approved Firazyr ( Icatibant ) injection for the treatment of acute ...
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Stomach acid-reducing drugs: proton pump inhibitors may be dangerous

Many widely prescribed stomach acid-reducing drugs can cause long-term dependence and should carry the strongest possible warning label for this ...
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Acute myocardial infarction: a single bolus of Epoetin alfa does not improve left ventricular ejection fraction

Results from the HEBE III study, a prospective, randomised, multicentre trial performed in seven centres in the Netherlands, suggest that ...
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Relapsing-remitting multiple sclerosis: Daclizumab HYP reduces annualized relapse rate

Biogen Idec and Abbott have announced results from SELECT, a global, registrational Phase 2b clinical trial designed to evaluate the ...
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STEMI patients undergoing primary PCI - Three-year follow-up for MULTISTRATEGY trial: Tirofiban versus Abciximab

Long-term, three-year, mortality data was presented from the Phase III, open label, multinational study comparing high-dose bolus ( HDB ) ...
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Hormone positive and HER2-positive advanced breast cancer: Tykerb in combination with Femara

The FDA ( Food and Drug Administration ) approved Tykerb ( Lapatinib ) in combination with Femara ( Letrozole ) ...
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FDA: Afinitor approved for progressive neuroendocrine tumors of pancreatic origin

The FDA ( Food and Drug Administration ) has approved Everolimus ( Afinitor tablets ) for the treatment of progressive ...
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Revlemid: risk of thrombosis and thromboembolism

Patients receiving Lenalidomide for the management of multiple myeloma should be closely monitored for evidence of arterial and venous thromboembolic ...
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Diabetes mellitus: use of Pioglitazone for more than one year associated with an increased risk of bladder cancer

The FDA ( Food and Drug Administration ) has informed the public that the Agency has approved updated drug labels ...
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Bydureon improves glycemic control more than daily oral Sitagliptin or Pioglitazone and induces more weight loss

DURATION-2 study has shown that a once-weekly injection of Exenatide ( Bydureon ) in patients with type 2 diabetes mellitus ...
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Permanent atrial fibrillation: Multaq and increased risk of death and serious cardiovascular adverse events

The FDA ( Food and Drug Administration ) is reviewing data from a clinical trial that was evaluating the effects ...
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Systemic lupus erythematosus: EMA has approved Benlysta

GlaxoSmithKline ( GSK ) and Human Genome Sciences have announced that the European Commission ( EC ) has granted marketing ...
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Gilenya: FDA has approved first oral drug to reduce multiple sclerosis relapses

The FDA ( Food and Drug Administration ) has approved Gilenya capsules ( Fingolimod ) to reduce relapses and delay ...
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Children born to mothers who took Valproate products while pregnant may have impaired cognitive development

The FDA ( Food and Drug Administration ) has informed the public that children born to mothers who take the ...
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Arcapta Neohaler to treat COPD: FDA approved

The FDA ( Food and Drug Administration ) has approved Arcapta Neohaler ( Indacaterol inhalation powder ) for the long ...
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