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European Union: Keytruda, an anti-PD-1 therapy, approved for metastatic microsatellite instability-high colorectal cancer patients

The European Commission ( EC ) has approved Keytruda ( Pembrolizumab ), an anti-PD-1 therapy, as a monotherapy for the first-line treatment of adult patients with metastatic microsatellite instability ... read article

FDA has approved Verquvo for patients with symptomatic chronic heart failure

The U.S. Food and Drug Administration ( FDA ) has approved soluble guanylate cyclase ( sGC ) stimulator Vericiguat under the brand name Verquvo. Vericiguat 2.5 mg, 5 mg, and 10 mg is indicated to re ... read article

Donanemab slows clinical decline of Alzheimer's disease

Donanemab, an investigational antibody that targets a modified form of beta amyloid called N3pG, showed significant slowing of decline in a composite measure of cognition and daily function in patient ... read article

FDA has approved Onureg for acute myeloid leukemia

The FDA ( Food and Drug Administration ) has approved Azacitidine tablets ( Onureg ) for continued treatment of patients with acute myeloid leukemia who achieved first complete remission ( CR ) or com ... read article

FDA has approved Alunbrig for ALK-positive metastatic non-small cell lung cancer

The FDA ( Food and Drug Administration ) has approved Alunbrig ( Brigatinib ) for adult patients with anaplastic lymphoma kinase ( ALK )-positive metastatic non-small cell lung cancer ( NSCLC ) as det ... read article

ACTT-2 trial: Baricitinib has significant effect on recovery time in COVID-19 patients requiring Oxygen

Baricitinib in combination with Remdesivir has reduced time to recovery and improved clinical outcomes for patients with COVID-19 infection compared with Remdesivir. This finding was part of additio ... read article

CheckMate -649: overall survival and progression-free survival was superior with Nivolumab plus chemotherapy versus chemotherapy in first-line treatment of gastric and esophageal cancers

CheckMate -649, a pivotal phase 3 trial evaluating Nivolumab ( Opdivo ) plus chemotherapy compared to chemotherapy alone as a first-line treatment for metastatic gastric cancer, gastroesophageal junct ... read article

Tecartus: the first and only CAR T treatment for relapsed or refractory mantle cell lymphoma, FDA approved

The U.S. Food and Drug Administration ( FDA ) has granted accelerated approval to Tecartus ( Brexucabtagene autoleucel, formerly KTE-X19 ), the first and only approved chimeric antigen receptor ( CAR ... read article

Keytruda approved by FDA for patients with TMB-high solid tumors

The FDA ( Food and Drug Administration ) has approved Keytruda ( Pembrolizumab ) for the treatment of adults and pediatric patients with unresectable or metastatic tumor mutational burden-high ( TMB-H ... read article

Atezolizumab in combination with chemotherapy has met primary endpoint of improved pCR, regardless of PD-L1 status, as initial treatment for patients with early triple-negative breast cancer

The phase III IMpassion031 study, evaluating Atezolizumab ( Tecentriq ) in combination with chemotherapy ( Abraxane, albumin-bound Paclitaxel; nab-Paclitaxel; followed by Doxorubicin and Cyclophospham ... read article

RECOVERY trial: Dexamethasone reduces COVID-19 patient deaths by one-third

A trial launched in March 2020 has released its results, finding that Dexamethasone reduced deaths of ventilated COVID-19 patients by one-third. The RECOVERY trial was established as a randomised c ... read article

CITYSCAPE trial: promising results adding Tiragolumab to Atezolizumab in patients with PD-L1-positive metastatic non-small cell lung cancer

Results from the phase II CITYSCAPE trial were published. This is the first randomised study evaluating the efficacy and safety of Tiragolumab plus Atezolizumab ( Tecentriq ) compared with Atezolizuma ... read article

CheckMate -9ER trial: Cabozantinib in combination with Nivolumab has shown clinically meaningful efficacy results across all endpoints in untreated advanced renal cell carcinoma

CheckMate -9ER, a pivotal phase III trial evaluating Cabozantinib ( Cabometyx ) in combination with Nivolumab ( Opdivo ) compared to Sunitinib in previously untreated advanced or metastatic renal cell ... read article

Osimertinib, phase III ADAURA trial will be unblinded early after overwhelming efficacy in the adjuvant treatment of patients with EGFR-mutated lung cancer

The ADAURA phase III trial for Tagrisso ( Osimertinib ) in the adjuvant treatment of patients with stage IB, II and IIIA epidermal growth factor receptor-mutated ( EGFRm ) non-small cell lung cancer ( ... read article

FDA has approved clinical trial for Tocilizumab to treat hospitalized patients with severe COVID-19 pneumonia

The FDA ( U.S. Food & Drug Administration ) has approved a randomized, double-blind, placebo-controlled phase III clinical trial in collaboration with BARDA ( Biomedical Advanced Research and Deve ... 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