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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

CHMP positive opinion for Keytruda for the treatment of advanced non-small cell lung cancer

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 ), the anti-PD-1 t ... read article

FDA has approved Cabometyx tablets for patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy

The U.S. Food and Drug Administration ( FDA ) has approved Cabometyx ( Cabozantinib ) tablets for the treatment of patients with advanced renal cell carcinoma ( RCC ) who have received prior anti-angi ... read article

Epclusa for the treatment of all genotypes of chronic hepatitis C, CHMP has adopted positive opinion

The Committee for Medicinal Products for Human Use ( CHMP ), of the European Medicines Agency ( EMA ), has adopted a positive opinion for Epclusa, an investigational, pan-genotypic, once-daily tablet ... read article

Selumetinib for adjuvant treatment of patients with stage III or IV differentiated thyroid cancer

The FDA ( Food and Drug Administration ) has granted Orphan Drug Designation for the investigational MEK 1/2 inhibitor, Selumetinib for adjuvant treatment of patients with stage III or IV differentiat ... read article

Zepatier for the treatment of chronic hepatitis C virus in adult patients, positive opinion from CHMP

The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has adopted a positive opinion recommending approval of Zepatier ( Elbasvir and Grazoprevir ), an i ... read article

Positive CHMP opinion to extend indication of Kyprolis for the treatment of relapsed multiple myeloma

The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has adopted a positive opinion to extend the current indication for Kyprolis ( Carfilzomib ) to inc ... read article

FDA: Breakthrough Therapy Designation for Keytruda in classical Hodgkin lymphoma

The FDA ( Food and Drug Administration ) has granted Breakthrough Therapy designation to Keytruda ( Pembrolizumab ), an anti-PD-1 therapy, for the treatment of patients with relapsed or refractory cla ... read article

FDA grants priority review for Atezolizumab, a cancer immunotherapy, in locally advanced or metastatic non-small cell lung cancer whose disease expresses the protein PD-L1

The FDA ( Food and Drug Administration ) has accepted the Biologics License Application ( BLA ) and granted Priority Review for Atezolizumab ( anti-PDL1; MPDL3280A ) for the treatment of people with l ... read article

Nivolumab for the treatment of patients with classical Hodgkin lymphoma

Bristol-Myers Squibb is seeking to extend the current indications for Opdivo ( Nivolumab ) to include the treatment of patients with classical Hodgkin lymphoma ( cHL ) after prior therapies. The ap ... read article

Cancer immunotherapy: FDA grants priority review for Atezolizumab in locally advanced or metastatic non-small cell lung cancer

LEADER trial: Liraglutide significantly reduces the risk of major adverse cardiovascular events

The results from the LEADER trial, which investigated the cardiovascular safety of Liraglutide ( Victoza ) over a period of up to 5 years in more than 9,000 adults with type 2 diabetes mellitus at hig ... read article

Label variation for Adcetris - Retreatment of adult patients with relapsed or refractory Hodgkin lymphoma and systemic anaplastic large cell lymphoma, European Commission approved

The European Commission ( EC ) has approved a Type II variation for Adcetris ( Brentuximab vedotin ) to include data on the retreatment of adult patients with relapsed or refractory ( R/R ) Hodgkin ly ... 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