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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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U.S. FDA says Indian drugmaker Strides Pharma Science was shredding, dumping key documents

A U.S. FDA investigator discovered that India’s Strides Pharma Science Ltd. – which exports to the U.S. market – was shredding drug production, quality and laboratory documents.

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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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AstraZeneca’s Farxiga fails to receive U.S. approval for type 1 diabetes

The U.S. Food and Drug Administration declined to approve AstraZeneca Plc’s diabetes treatment Farxiga for use as a supplement to insulin in adults with a rare type of the condition.

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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 Accepts New Drug Application for RedHill’s Talicia

RedHill Biopharma Ltd. announced that the U.S. Food and Drug Administration accepted for review the New Drug Application for Talicia (RHB-105) for H. pylori infection.

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GSK’s HIV drug receives EU marketing nod

GlaxoSmithKline’s ViiV Healthcare received European Commission approval for Dovato to treat advanced-stage HIV infections in adults and adolescents above the age of 12 and weighing at least 40 kg.

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Gilead Announces Intent to Submit New Drug Application for Filgotinib to U.S. FDA in 2019

Gilead Sciences announced that a path forward was established to submit a New Drug Application in 2019 for the investigational oral, selective JAK1 inhibitor filgotinib as a rheumatoid arthritis treatment.

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


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