FDA Approvals

Sanofi announced that the U.S. FDA approved once-daily Soliqua 100/33 100 Units/mL & 33 mcg/mL for the treatment of adults with type 2 diabetes...

Sandoz’s Erelzi receives FDA Approval making it the First US Enbrel Biosimilar

Americas

Sandoz, a Novartis company, has announced its drug, Erelzi, has been approved by the FDA, in a significant development. ...

Teva Secures EU Approval of Trisenox for First Line Treatment of Low to Intermediate Risk Acute Promyelocytic Leukemia

FDA Approvals

Teva Pharmaceutical Industries Ltd announced it has obtained approval from the European Commission for an indication extension of Trisenox® (arsenic trioxide). This marks an...

Spark Therapeutics and Pfizer receives FDA Designation for SPK-9001

Americas

Spark Therapeutics and Pfizer Inc announced that the U.S. FDA has granted breakthrough therapy designation to SPK-9001, the lead investigational candidate in the companies’...

Sandoz Biosimilar Etanercept Recommended By Fda For Approval To Treat Multiple Inflammatory Diseases

Americas

Sandoz, a Novartis division and leader in biosimilars, announced today that the US FDA Advisory Committee recommended approval of its proposed biosimilar etanercept. The...

U.S. FDA Grants Priority Review to Janssen’s New Drug Application for Chewable Mebendazole Tablets

Americas

Janssen Pharmaceuticals, Inc one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), announced today that the U.S. Food and Drug Administration (FDA)...

US FDA approves expanded label for self-infusion of Glassia to treat emphysema due to severe AAT deficiency

FDA Approvals

Shire plc and Kamada Ltd a plasma-derived protein therapeutics company focused on orphan indications, announced that the US FDA has approved an expanded label...

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