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Afstyla is the first and only single-chain therapy for haemophilia A, approved by European Commission

The European Commission has granted marketing authorisation for Afstyla [ recombinant human coagulation Factor VIII, single chain ] for children and adults with haemophilia A. Afstyla is the first a ... read article

Lucentis to treat patients for visual impairment due to choroidal neovascularization associated with causes other than neovascular age-related macular degeneration or secondary to pathologic myopia, EC approved

The European Commission ( EC ) has granted an additional indication for Lucentis ( Ranibizumab ) to treat patients with visual impairment due to choroidal neovascularization ( CNV ) associated with ca ... read article

Cimaglermin, a novel investigational drug, may help restore cardiac function after heart failure

Cimaglermin, a new experimental drug, may help restore cardiac function after heart failure, according to a first-in-man study published in JACC: Basic to Translational Science. Heart failure, char ... read article

Keytruda for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have high PD-L1 expression with no EGFR or ALK positive tumor mutations, recommended by CHMP for approval

The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has adopted a positive opinion recommending approval of Keytruda ( Pembrolizumab ), an anti-PD-1 th ... read article

Ibrance, a CDK 4/6 inhibitor, has received approval in European Union for the treatment of women with HR+/HER2- metastatic breast cancer

The European Commission ( EC ) has approved Ibrance ( Palbociclib ) for the treatment of women with hormone receptor-positive, human epidermal growth factor receptor 2-negative ( HR+/HER2- ) locally a ... read article

Tecentriq for the treatment of patients with metastatic non-small cell lung cancer whose disease progressed during or following Platinum-containing chemotherapy, approved by FDA

The FDA ( Food and Drug Administration ) ha approved Atezolizumab ( Tecentriq ) for the treatment of patients with metastatic non-small cell lung cancer ( NSCLC ) whose disease progressed during or fo ... read article

CHMP grants positive opinion for Venetoclax tablets for patients with difficult-to-treat chronic lymphocytic leukaemia

The European Committee for Medicinal Products for Human Use ( CHMP ) has granted a positive opinion for Venclyxto ( Venetoclax ) tablets for the treatment of chronic lymphocytic leukaemia ( CLL ) in t ... read article

Actemra in giant cell arteritis, a form of vasculitis: FDA grants Breakthrough Therapy Designation

The FDA ( Food and Drug Administration ) has granted Breakthrough Therapy Designation status to Actemra ( Tocilizumab; in Europe: RoActemra ) for giant cell arteritis ( GCA ), a chronic, potentially l ... read article

FDA has granted Breakthrough Therapy Designation for Alecensa for first-line treatment of people with ALK-positive non-small cell lung cancer

Alecensa ( Alectinib ), an ALK inhibitor, has received a second Breakthrough Therapy Designation ( BTD ) from the United States Food and Drug Administration ( FDA ). The latest BTD was granted for the ... read article

Breast cancer: Ibrance provides novel treatment option for women with advanced or metastatic disease

The European Medicines Agency ( EMA ) has recommended granting a marketing authorisation in the European Union ( EU ) for Ibrance ( Palbociclib ) for the treatment of women with locally advanced or me ... read article

Avastin in combination with Tarceva for patients with advanced, metastatic or recurrent non-squamous non-small cell lung cancer with EGFR-activating mutations, EC approved

The European Commission ( EC ) has approved the use of Avastin ( Bevacizumab ) in combination with Tarceva ( Erlotinib ) for the first-line treatment of adult patients with unresectable advanced, meta ... read article

Opdivo has received Breakthrough Therapy Designation from FDA for advanced urothelial carcinoma

The FDA ( Food and Drug Administration ) has granted Breakthrough Therapy Designation to Opdivo ( Nivolumab ) for the potential indication of unresectable locally advanced or metastatic urothelial car ... read article

Cabometyx for the treatment of advanced renal cell carcinoma

The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Cabometyx, intended for the ... read article

Kisplyx for the treatment of patients with unresectable advanced or metastatic renal cell carcinoma

The Committee for Medicinal Products for Human Use ( CHMP ) of EMA ( European Medicines Agency ) has adopted a positive opinion on Kisplyx for the treatment of patients with unresectable advanced or m ... read article

European Commission: Revlimid approved for the treatment of relapsed / refractory patients with mantle cell lymphoma

The European Commission ( EC ) has approved Revlimid ( Lenalidomide ) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma ( MCL ). Mantle cell lymphoma is a rare su ... read article

Focus

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 ( EC ) for the treatment of visual impairment due to macular edema seconda ... read article

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 shows real potential as a safe, effective, targeted treatment for adults with chro ... read article

Olmesartan Medoxomil can cause sprue-like enteropathy

FDA ( Food and Drug Administration ) has warned that the blood pressure drug Olmesartan Medoxomil ( marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics ) can cause intestinal problems know ... read article

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 UC San Francisco researcher, Carlo Maley, points to a possible explanation, with the discovery that A ... read article

Metastatic or unresectable melanoma: FDA approves Tafinlar and Mekinist

The Food and Drug Administration ( FDA ) has approved two new drugs, Tafinlar ( Dabrafenib ) and Mekinist ( Trametinib ), for patients with advanced ( metastatic ) or unresectable melanoma, the most d ... read article

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 and some adolescents with giant cell tumor of the bone ( GCTB ), a rare and usually non-cancerous t ... read article

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 III study PATENT-1, were presented at the American Thoracic Societ ... read article

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 treatment of adults with type 2 diabetes. Invokana is the first in a new ... read article