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EMA: Omega-3 fatty acid medicines no longer considered effective in preventing heart disease

EMA ( European Medicines Agency ) has concluded that Omega-3 fatty acid medicines are not effective in preventing further heart and blood vessels problems in patients who have had a myocardial infarct ... read article

FDA has approved Talzenna for gBRCAm HER2-negative locally advanced or metastatic breast cancer

The FDA ( Food and Drug Administration ) has approved Talzenna ( Talazoparib ), a poly (ADP-ribose) polymerase ( PARP ) inhibitor, for patients with deleterious or suspected deleterious germline BRCA- ... read article

FDA has approved twice-daily Xarelto 2.5-mg dose to reduce the risk of major cardiovascular events in patients with chronic coronary artery disease or peripheral artery disease

The U.S. Food and Drug Administration ( FDA ) has approved Xarelto ( Rivaroxaban ) to reduce the risk of major cardiovascular events, such as cardiovascular death, myocardial infarction and stroke, in ... read article

Lorbrena for previously-treated ALK-positive metastatic non-small cell lung cancer, approved from FDA

The FDA ( U.S. Food and Drug Administration ) has approved Lorbrena ( Lorlatinib ), a third-generation anaplastic lymphoma kinase ( ALK ) tyrosine kinase inhibitor ( TKI ) for patients with ALK-posit ... read article

Vizimpro for the first-line treatment of patients with EGFR-mutated metastatic non-small cell lung cancer, approved from FDA

The FDA ( U.S. Food and Drug Administration ) has approved Vizimpro ( Dacomitinib ), a kinase inhibitor for the first-line treatment of patients with metastatic non-small cell lung cancer ( NSCLC ) w ... read article

SOLO-1 trial: Olaparib maintenance therapy cut risk of disease progression or death by 70% in patients with newly-diagnosed, advanced BRCA-mutated ovarian cancer

The results from the phase III SOLO-1 trial testing Olaparib ( Lynparza ) tablets as a maintenance treatment for patients with newly-diagnosed, advanced BRCA-mutated ( BRCAm ) ovarian cancer who were ... read article

Locally-advanced, unresectable non-small cell lung cancer: approved Imfinzi in European Union

The European Commission has granted marketing authorisation for Imfinzi ( Durvalumab ) as monotherapy for the treatment of locally-advanced, unresectable non-small cell lung cancer ( NSCLC ) in adults ... read article

FDA: Breakthrough Therapy Designation for LOXO-292, a selective RET inhibitor

The FDA ( U.S. Food and Drug Administration ) has granted Breakthrough Therapy Designation to LOXO-292, a selective RET inhibitor, for: the treatment of patients with metastatic RET-fusion-positive no ... read article

Target therapy: RG6042, an antisense oligonucleotide, for treatment of Huntington’s disease

The European Medicines Agency ( EMA ) has granted PRIME ( PRIority MEdicines ) designation for an investigational medicine RG6042 ( formerly known as IONIS-HTTRx ) for the treatment of people with Hun ... read article

Imbruvica plus Rituximab approved by FDA as first chemotherapy-free combination treatment in adults with Waldenström's macroglobulinemia

The U.S. Food and Drug Administration ( FDA ) has approved Imbruvica ( Ibrutinib ) plus Rituximab ( Rituxan ) for the treatment of adult patients with Waldenström's macroglobulinemia ( WM ), a rare an ... read article

Yescarta has received European marketing authorization for the treatment of relapsed or refractory diffuse large B-cell lymphom and primary mediastinal large B-cell lymphoma

The European Commission ( EC ) has granted Marketing Authorization for Yescarta ( Axicabtagene ciloleucel ) as a treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma ... read article

Biktarvy for the treatment of HIV-1 infection, approved by European Commission

European Commission has granted Marketing Authorization for Biktarvy ( Bictegravir 50mg / Emtricitabine 200 mg / Tenofovir alafenamide 25 mg; BIC/FTC/TAF ), a once-daily single tablet regimen ( STR ) ... read article

Braftovi plus Mektovi for BRAF V600E, V600K mutation-positive melanoma: FDA approved

The FDA ( US Food and Drug Administration ) has granted approval to Encorafenib ( Braftovi ) and Binimetinib ( Mektovi ) combination therapy for the treatment of patients with unresectable or metastat ... read article

Ovarian cancer: Olaparib significantly delays disease progression in 1st-line SOLO-1 trial

Olaparib ( Lynparza ) met primary endpoint of progression-free survival in women with BRCA-mutated advanced ovarian cancer and showed a safety profile in SOLO-1 trial consistent with previous trials. ... read article

Durvalumab improves overall survival in PACIFIC trial for unresectable stage III non-small cell lung cancer

Positive overall survival ( OS ) results for the phase III PACIFIC trial, a randomised, double-blinded, placebo-controlled, multi-centre trial of Durvalumab ( Imfinzi ) in patients with unresectable s ... 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