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Merck’s Pifeltro and Delstrigo Receive FDA Approval for Virologically Suppressed Adults with HIV-1

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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FDA Approves Keytruda-Lenvima Combo Treatment for Certain Types of Endometrial Carcinoma

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’s Phase 3 Study of CC-486 as Maintenance Therapy in Patients With Newly Diagnosed AML Met Primary and Key Secondary Endpoints

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 Receives FDA Breakthrough Designation for Nerve Regeneration Device

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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European Commission approves MM drug EPd

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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U.S. FDA Grants Application Priority Review for the Treatment of Men with Metastatic Hormone-Sensitive Prostate Cancer

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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European Medicines Agency Validates Marketing Application for Filgotinib for the Treatment of Rheumatoid Arthritis

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, Merck Collaboration Aims to Discover New Immuno-oncology Targets

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 Receives FDA CRL for KPI-121 0.25% NDA

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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Veteran Broadcast Journalist Barbara Pinto Joins W2O Executive Communications Practice

W2O announced that former network news reporter Barbara Pinto has been named Practice Leader, Executive Communications.

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