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Amicus receives U.S. approval for Fabry disease drug

U.S. health regulators approved Amicus Therapeutics’ Galafold as the first oral therapy to treat Fabry disease, a rare and sometimes fatal condition.

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Alnylam’s gene silencing drug wins FDA approval

Alnylam Pharmaceuticals’ Onpattro won U.S. regulatory approval for a rare hereditary disease, becoming the first approved treatment from a new class of medicines that use gene silencing technology.

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FDA Approves Malaria Drug Arakoda

The U.S. FDA approved 60 Degrees Pharmaceuticals’ Arakoda (tafenoquine) tablets for the prevention of malaria in patients aged 18 years and older.

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Top 200 Medicines Annual Report 2018: Blockbusters thriving despite tumultuous climate

There were as many billion-dollar brands in 2017 as there have been in any other calendar year despite the cratering effects of massive patent cliffs in 2012 and 2015.

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First Year After Launch Special Feature 2018: Don’t look back, someone might be gaining

The top performers of the launch class of 2016 have very little in common – aside from the fact that none of them came from a “classic” big pharma house.

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FDA Approves Orkambi For New Cystic Fibrosis Use

The FDA approved Vertex Pharmaceuticals’ Orkambi (lumacaftor/ivacaftor) to include use in children ages 2-5 years with cystic fibrosis who have two copies of the F508del-CFTR mutation.

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Breast Cancer Device Receives FDA Approval

The U.S. Food and Drug Administration approved the first non-radioactive, dual-tracer for sentinel lymph node biopsy.

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FDA approves first treatment for rare adrenal tumors

The FDA approved Azedra injection for intravenous use for treating patients age 12 and older with rare tumors of the adrenal gland that cannot be surgically removed, have spread beyond the original tumor site and require systemic anticancer therapy.

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AbbVie, Neurocrine Snag FDA Approval for Oral Endometriosis Treatment Elagolix

Shares of AbbVie were up after the FDA granted regulatory approval for the company’s endometriosis drug Orilissa (elagolix).

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U.S. FDA Approves Pfizer’s Biosimilar Nivestym

Pfizer Inc. announced that the U.S. FDA approved Nivestym (filgrastim-aafi), a biosimilar to Neupogen, for all eligible indications of the reference product.

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


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