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Amgen's Bkemv Approved As First Interchangeable Biosimilar To Soliris
The U.S. Food and Drug Administration has approved Amgen Inc.'s Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab), developed by British drug major AstraZeneca's Rare Disease unit Alexion Pharmaceuticals, to treat certain rare diseases. Soliris is a medicine used to treat adults and children with paroxysmal nocturnal haemoglobinuria or PNH...
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Amgen To Open Manufacturing Site In Central Ohio; To Offer 400 Full-time Jobs
Amgen, Inc. (AMGN) announced Monday the opening of its manufacturing site in Central Ohio, the newest in its global operations network and the most advanced facility to date.
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Amgen Says FDA Completes Review Of SNDA Seeking Full Approval For LUMAKRAS
Amgen, Inc. (AMGN) announced Tuesday that the U.S. Food and Drug Administration (FDA) has completed its review of the company's supplemental New Drug Application seeking full approval of LUMAKRAS (sotorasib).
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Amgen, Horizon Therapeutics Reach Settlement On FTC Lawsuit; Seeks To Close Acquisition In Q4
Amgen (AMGN) and Horizon Therapeutics plc (HZNP) announced Friday the entry into a consent order agreement with the Federal Trade Commission (FTC) that resolves the pending FTC administrative lawsuit. This clears the path to take the final steps to close Amgen's $27.8 billion acquisition of Horizon.
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Amgen Announces Positive Top-line Results From Phase 3 DAHLIA Study Of ABP 959
Amgen, Inc. (AMGN) announced Tuesday positive top-line results from the DAHLIA study, a randomized, double-blind, active-controlled, two-period crossover Phase 3 study evaluating the efficacy and safety of ABP 959, a biosimilar candidate to SOLIRIS (eculizumab), compared with SOLIRIS in adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
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