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The Pulse of the Pharmaceutical Industry

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Newest Generation Of Leading Heart Stent Approved In U.S. For People With Coronary Artery Disease

Abbott received approval from the U.S. Food and Drug Administration for XIENCE Sierra, the newest generation of the gold-standard XIENCE everolimus-eluting coronary stent system.

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FDA Grants Breakthrough Therapy Designation for Tafamidis for the Treatment of Patients with Transthyretin Cardiomyopathy

Pfizer Inc. announced that tafamidis received Breakthrough Therapy designation from the U.S. Food and Drug Administration for the treatment of patients with transthyretin cardiomyopathy, which is a rare, fatal and underdiagnosed condition associated with progressive heart failure.

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Keytruda succeeds in late-stage lung cancer study

Merck & Co.’s cancer drug Keytruda helped extend survival and prevented disease progression when tested in a late-stage study in combination with chemotherapy for a type of lung cancer.

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Lilly’s Taltz Receives First U.S. FDA Approval for Label Update to Include Data for Psoriasis Involving Genital Area

Eli Lilly and Company announced that the U.S. Food and Drug Administration approved a label update for Taltz (ixekizumab) injection 80 mg/mL to include data in psoriasis involving the genital area.

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FDA Advisory Committee Votes in Favor of Waylivra for Treatment of FCS

Akcea Therapeutics Inc. announced that the U.S. Food and Drug Administration’s Division of Metabolism and Endocrinology Products Advisory Committee voted 12-8 to support approval of Waylivra (volanesorsen) for the treatment of people with familial chylomicronemia syndrome.

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FDA says Mylan’s EpiPen is in shortage

U.S. regulators said Mylan NV’s EpiPen products are in shortage, due to manufacturing delays that are creating intermittent supply constraints of the emergency allergy treatment.

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AcelRx resubmits New Drug Application for DSUVIA

Specialty pharmaceutical company AcelRx Pharmaceuticals Inc. announced the resubmission of the New Drug Application (NDA) for DSUVIA with the U.S. FDA.

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Biotechs Develop Treatments Targeting Multiple Types of Mental Illness

An estimated 25 percent of adults in the United States will deal with some form of mental illness within a given year. It’s also estimated that many of the people who experience these problems may never report it or seek help – despite a number of available therapies.

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Delayed calorie disclosure rule takes effect for U.S. food sellers

Many restaurants, supermarkets, convenience stores and movie theaters across the United States are required to start clearly displaying food calorie counts as part of a push to trim expanding American waistlines and control healthcare costs.

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FDA chief questions protections on drug rebates, stocks fall

U.S. Food and Drug Administration chief Scott Gottlieb questioned whether rebates that drugmakers provide to health insurers should remain protected by federal law, sparking new concerns on Wall Street over efforts to curb drug pricing.

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April 2019 Focus: Healthcare agency & network profiles, industry overview & awards, and more!


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