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The Pulse of the Pharmaceutical Industry

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Merck’s infections drug Recarbrio wins FDA approval

The U.S. Food and Drug Administration approved Merck & Co. Inc.’s combination treatment for complicated forms of urinary tract and abdominal infections.

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FDA approves Bayer’s Gadavist injection

The FDA approved Gadavist for use in cardiac magnetic resonance imaging to assess myocardial perfusion and late gadolinium enhancement in adults with known or suspected CAD.

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Azurity Pharmaceuticals Wins FDA Approval for Liquid Form of Amlodipine

Privately held Azurity Pharmaceuticals won approval for a liquid form of a hypertension drug for both adult and pediatric patients.

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After Rocky Road, Karyopharm Wins FDA Approval for Multiple Myeloma Drug

Shares of Karyopharm Therapeutics skyrocketed more than 36 percent after the U.S. Food and Drug Administration approved the Newton, Mass.-based company’s Xpovio for treating multiple myeloma.

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FDA Approves Retrophin’s New Formula for Cystine Kidney Stones

The FDA approved San Diego-based Retrophin Inc.’s 100 mg and 300 mg tablets of Thiola EC (tiopronin) to treat cystinuria.

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FDA Greenlights Soliris for Rare Autoimmune Disease

The U.S. FDA gave Alexion Pharmaceuticals a thumbs-up for Soliris (eculizumab) to treat neuromyelitis optica spectrum disorder in adults that express a specific biomarker.

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Pfizer’s Avastin biosimilar wins FDA approval

The U.S. Food and Drug Administration approved Pfizer Inc.’s biosimilar to Roche Holding AG’s blockbuster cancer treatment Avastin.

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FDA approves expanded label for Regeneron/Sanofi’s Dupixent

The U.S. Food and Drug Administration approved Regeneron Pharmaceuticals Inc. and Sanofi SA’s drug Dupixent to treat nasal polyps, marking the third major use for the injectable medicine.

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FDA declines to approve Acer’s Edsivo for vEDS

The U.S. FDA declined to approve Acer Therapeutics Inc.’s Edsivo for a severe, rare genetic disorder – vascular Ehlers-Danlos syndrome (vEDS) – that can cause blood vessels to fatally rupture.

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FDA approves drug for loss of sexual desire in women

The U.S. drug regulator approved Palatin Technologies and Amag Pharmaceuticals’ drug to restore sexual desire in premenopausal women.

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June 2019 Focus: Payer access, biotech/biopharma, DTC, rare diseases, and more!


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