Tag Archives: Mylan

November, 2018

  • 9 November

    FDA Approves Yupelri for Maintenance Treatment of Adult Patients with COPD

    DUBLIN, Ireland, HERTFORDSHIRE, England and PITTSBURGH, Nov. 9, 2018 /PRNewswire/ — Theravance Biopharma, Inc. (NASDAQ: TBPH) (“Theravance Biopharma”) and Mylan N.V. (NASDAQ: MYL) (“Mylan”) today announced that the U.S. Food and Drug Administration (FDA) has approved the  New Drug Application (NDA) for YUPELRITM (revefenacin) inhalation solution for the maintenance treatment of patients …

September, 2018

June, 2018

  • 5 June

    FDA Approves Mylan and Biocon’s Fulphila, the First Biosimilar to Neulasta

    HERTFORDSHIRE, England and PITTSBURGH and BENGALURU, India, June 4, 2018/PRNewswire/ — Mylan N.V. (NASDAQ: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) has approved Mylan’s Fulphila™ (pegfilgrastim-jmbd), a biosimilar to Neulasta® (pegfilgrastim), co-developed with Biocon. Fulphila has been approved to reduce the duration of febrile neutropenia (fever …

January, 2018

  • 31 January

    FDA Accepts Theravance and Mylan’s NDA for Revefenacin for the Treatment of Adults with COPD

    DUBLIN and HERTFORDSHIRE, England and PITTSBURGH, Jan. 29, 2018 /PRNewswire/ — Theravance Biopharma, Inc. (NASDAQ: TBPH) (“Theravance Biopharma”) and Mylan N.V. (NASDAQ, TASE: MYL) (“Mylan”) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the companies’ recently submitted New Drug Application (NDA) for revefenacin (TD-4208), an investigational long-acting muscarinic antagonist (LAMA). If approved, revefenacin would be the …

December, 2017

October, 2017

July, 2017

March, 2017

February, 2017

January, 2017