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The FDA has granted priority review for Bristol-Myers Squibb and AbbVie’s Empliciti for the treatment of multiple myeloma in patients who have received one or more previous therapies — giving it a PDUFA date of Feb. 29, 2016. Read More
Australian regulators have approved Hospira’s Inflectra as the country’s first monoclonal antibody biosimilar, a version of Janssen’s autoimmune disease therapy Remicade. Read More
Swiss regulators have approved Exelixis’ cobimetinib for use in combination with Genentech’s Zelboraf to treat advanced melanoma — allowing the company to begin marketing the drug while it awaits regulatory decisions in the U.S. and EU. Read More
The FDA approved Amgen’s Repatha late Thursday for some patients who are not able to control low-density lipoprotein cholesterol using standard treatment options, making it the second PCSK9 inhibitor to receive the agency’s blessing. Read More
Amgen is seeking FDA approval for etelcalcetide — the first calcimimetic agent for secondary hyperparathyroidism in patients with chronic kidney disease that can be administered intravenously at the end of a dialysis session. Read More