Press Releases

 
Press Releases
  Date Title and Summary View
Dec 14, 2017
HERTFORDSHIRE, England and PITTSBURGH, Dec. 14, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) today announced that the U.S. Patent and Trademark Appeal Board (PTAB) has instituted inter partes review (IPR) proceedings on all claims against two Orange Book-listed patents, U.S. Patent Nos. 7,476,652 and 7,713,930, owned by Sanofi for Lantus...
Dec 11, 2017
HERTFORDSHIRE, England and PITTSBURGH, Dec. 11, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) today announced that Teva has dismissed its pending district court litigation against Mylan regarding Mylan's Glatiramer Acetate Injection 40 mg/mL, the first generic version of Copaxone® 40 mg/mL. The litigation involved two non-Orange Book lis...
Dec 4, 2017
HERTFORDSHIRE, England, PITTSBURGH and DURBAN, South Africa, Dec. 4, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) and its partner, Aspen (JSE: APN), today announced the U.S. launch of Myleran (busulfan) Injection, 60 mg/10 mL (6 mg/mL) Single-dose Vial, a generic version of Otsuka Pharmaceutical's Busulfex® Injection. Aspen received fin...
Dec 1, 2017
HERTFORDSHIRE, England, PITTSBURGH and BENGALURU, India, Dec. 1, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) has approved Mylan's Ogivri™ (trastuzumab-dkst), a biosimilar to Herceptin® (trastuzumab), co-developed with ...
Dec 1, 2017
HERTFORDSHIRE, England and PITTSBURGH, Dec. 1, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL), a global pharmaceutical company, today announced it has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDAs) for Heparin Sodium Injection USP, 1,000 USP/mL, 5,000 USP/mL, 10,000 US...
Nov 30, 2017
HERTFORDSHIRE, England, PITTSBURGH and BENGALURU, India, Nov. 30, 2017 /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 Applications (MAA) for proposed biosimilar trastuzumab and proposed bio...
Nov 20, 2017
HERTFORDSHIRE, England and PITTSBURGH, Nov. 20, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) today announced that its president, Rajiv Malik, will present at the Evercore ISI Inaugural Biopharma Catalyst/Deep Dive Conference in Boston, Mass., on Thursday, Nov. 30, 2017, at 3:50 p.m. ET. The discussion will focus on Mylan's robust pipeline an...
Nov 13, 2017
DUBLIN and HERTFORDSHIRE, England and PITTSBURGH, Nov. 13, 2017 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma") and Mylan N.V. (NASDAQ, TASE: MYL) ("Mylan") today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for revefenacin (TD-4208), an investigational lo...
Nov 10, 2017
HERTFORDSHIRE, England and PITTSBURGH, Nov. 10, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) today announced that it is voluntarily delisting the company's ordinary shares from trading on the Tel Aviv Stock Exchange (TASE). Under Israeli law, the delisting of Mylan's ordinary shares from the TASE will become effective in three months, on Feb...
Nov 9, 2017
HERTFORDSHIRE, England and PITTSBURGH, Nov. 9, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) today announced the U.S. launch of Clofarabine Injection, 20 mg/20 mL (1 mg/mL) Single-Dose Vials, a generic version of Genzyme's Clolar®. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug...
Page:
1
... NextLast
= add release to Briefcase