Press Releases

 
Press Releases
  Date Title and Summary View
Nov 10, 2016
Nov 9, 2016
HERTFORDSHIRE, England and PITTSBURGH, Nov. 9, 2016 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) today announced its financial results for the quarter and nine months ended September 30, 2016. Third Quarter 2016 Financial Highlights Total revenues and adjusted total revenues of $3.06 billion, each up 13% compared to the pri...
Nov 8, 2016
HERTFORDSHIRE, England, PITTSBURGH and BENGALURU, India, Nov. 8, 2016 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced submission of Mylan's biologics license application (BLA) for MYL-1401O, a proposed biosimilar trastuzumab, to the U.S. Food and Drug Administration (FDA) through the 35...
Nov 3, 2016
HERTFORDSHIRE, England, PITTSBURGH and BENGALURU, India, Nov. 3, 2016 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the European Medicines Agency (EMA) has accepted for review Mylan's Marketing Authorization Application (MAA) for insulin glargine, a long-acting insulin analog use...
Nov 2, 2016
CAMBRIDGE, Mass. and HERTFORDSHIRE, England and PITTSBURGH, Nov. 2, 2016 /PRNewswire/ -- Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA) and Mylan N.V. (NASDAQ, TASE: MYL), today announced that dosing has begun in a Phase 1 study to compare the pharmacokinetics, safety and immunogenicity of M834, a proposed biosimilar of ORENCIA (abatacept), to US- an...
Oct 26, 2016
HERTFORDSHIRE, England and PITTSBURGH, Oct. 26, 2016 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) today announced the U.S. launches of the first generic versions of Daiichi Sankyo's Benicar® and Benicar HCT®, Olmesartan Medoxomil Tablets, 5 mg, 20 mg and 40 mg, and Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 20 mg/12.5 mg, 40 ...
Oct 20, 2016
DUBLIN and HERTFORDSHIRE, England and PITTSBURGH, Oct. 20, 2016 /PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma") and Mylan N.V. (NASDAQ, TASE: MYL) ("Mylan") today announced positive results from two replicate Phase 3 efficacy studies of revefenacin (TD-4208), an investigational long-acting muscarinic antagonist (LAMA) and the fi...
Oct 7, 2016
WASHINGTON, Oct. 7, 2016 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) today announced that its subsidiary, Mylan Inc., has agreed to the terms of a $465 million settlement with the U.S. Department of Justice ("DOJ") and other government agencies that will resolve questions that have been raised about the classification of EpiPen® Auto-Inject...
Sep 30, 2016
HERTFORDSHIRE, England and PITTSBURGH, Sept. 30, 2016 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) today announced the U.S. launch of Metformin Hydrochloride Extended-release Tablets USP, 500 mg and 1000 mg, a generic version of Watson's Fortamet®. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbrevi...
Sep 1, 2016
HERTFORDSHIRE, England and PITTSBURGH, Sept. 1, 2016 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) today announced that the U.S. Patent and Trademark Office (PTO) has ruled in favor of Mylan in its inter partes review (IPR) proceeding and found all claims of U.S. Patent No. 8,969,302, which is owned by Yeda Research & Development Co., Ltd. and lic...
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