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FDA Advisory Panel Gives Mixed Review to Sanofi’s Dengue Vaccine

A mixed review from a U.S. FDA panel of experts could sink the chances of a green light for Sanofi’s dengue vaccine Dengvaxia.

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EC approves Roche’s Tecentriq combo vs. lung cancer

Roche received European Commission (EC) approval for the company’s Tecentriq drug in combination with Avastin and chemo as an initial treatment for people with a specific type of lung cancer.

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European Commission Approves Clovis Oncology’s Rubraca Tablets as Maintenance Treatment for Relapsed Ovarian Cancer

Clovis Oncology Inc. announced that the European Commission approved the use of Rubraca (rucaparib) for a second indication: as monotherapy for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.

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European Commission Approves Blincyto In Patients With Philadelphia Chromosome Negative Minimal Residual Disease-Positive B-cell Precursor Acute Lymphoblastic Leukemia

Amgen announced that the European Commission approved an expanded indication for Blincyto monotherapy to include adult patients with Philadelphia chromosome negative CD19 positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease greater than or equal to 0.1 percent.

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Xeljanz Receives EU Marketing Authorization For Moderately To Severely Active Ulcerative Colitis

Pfizer Inc. announced that the European Commission approved Xeljanz (tofacitinib citrate) 10 mg twice daily for at least eight weeks, followed by Xeljanz 5 mg BID or 10 mg BID, for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.

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European Commission Approves Bristol-Myers Squibb’s Opdivo For Adjuvant Therapy Melanoma Indication

The European Commission approved Bristol-Myers Squibb’s Opdivo (nivolumab) for the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

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Europe Approves Expanded Indication for Sprycel

The European Commission approved Sprycel (dasatinib) to include the treatment of children and adolescents aged 1 year to 18 years with Philadelphia chromosome-positive CML in chronic phase.

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Xeljanz Wins EU Approval for Active Psoriatic Arthritis

The European Commission approved Pfizer’s Xeljanz in combination with methotrexate for treating active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to a prior DMARD therapy.

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European Commission Approves Gilead’s Biktarvy

The European Commission granted Marketing Authorization for Gilead Sciences Inc.’s Biktarvy as a once-daily single tablet regimen for the treatment of HIV-1 infection.

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European Commission Approves Prolia for Patients With Glucocorticoid-Induced Osteoporosis

Amgen today announced that the European Commission approved a new indication for Prolia (denosumab) for the treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.

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