The U.S. FDA approved Merck’s supplemental New Drug Applications for Pifeltro (in combination with other antiretroviral agents) and Delstrigo (as a complete regimen) that expand their indications to include adult patients with HIV-1 infection who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to Pifeltro or the individual components of Delstrigo.
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The U.S. Food and Drug Administration approved a combination of Merck’s anti-PD-1 therapy Keytruda plus Eisai’s orally available kinase inhibitor Lenvima for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high or mismatch repair deficient, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation.
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Celgene Corporation announced top-line results from the international phase 3, randomized, double-blind, placebo-controlled study QUAZAR AML-001.
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Checkpoint Surgical Inc. – a leader in hand-held, intraoperative neurostimulation technology for nerve protection and repair – received Breakthrough Device designation from the U.S. Food and Drug Administration for the Checkpoint brief electrostimulation therapy (BEST) system.
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The European Commission approved Bristol-Myers Squibb Co.’s Empliciti plus pomalidomide and low-dose dexamethasone (EPd) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies.
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The U.S. Food and Drug Administration accepted for review Astellas Pharma Inc.’s filing of a supplemental New Drug Application for Xtandi (enzalutamide) to add an indication for the treatment of men with metastatic hormone-sensitive prostate cancer.
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Gilead Sciences Inc. and Galapagos NV announced that the Marketing Authorization Application for filgotinib – an investigational, oral, selective JAK1 inhibitor for the treatment of adults with rheumatoid arthritis – was validated and is under evaluation by the European Medicines Agency.
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Harvard University and Merck launched a collaboration that will provide significant research funding for up to four years to support immuno-oncology research led by Arlene Sharpe, MD, PhD, at Harvard Medical School (HMS).
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Kala Pharmaceuticals Inc. received a complete response letter from the U.S. Food and Drug Administration regarding the company’s new drug application for KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease.
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W2O announced that former network news reporter Barbara Pinto has been named Practice Leader, Executive Communications.
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