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Mylan Receives Tentative Approval for "TLE400" Under PEPFAR americanpharmaceuticalreview
March 22, 2017
Mylan has announced receipt of tentative approval from the U.S. Food and Drug Administration under the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application for Efavirenz...
Mylan announces global settlement and license Agreements with Genentech and Roche on Herceptin cphi-online
March 15, 2017
Settlement provides Mylan with global licenses for its trastuzumab product.
U.S. FDA accepts biologics license application for Mylan and Biocon’s proposed biosimilar pegfilgras pharmaasia
March 06, 2017
U.S. Food and Drug Administration has accepted Mylan's Biologics License Application (BLA) for MYL-1401H for filing through the 351(k) pathway.
Mylan reaches $96.5-million settlement regarding claims over generic Provigil firstwordpharma
February 07, 2017
Mylan agreed to pay $96.5 million to a group of drug purchasers to settle allegations made in 2006 that the company paid Cephalon to delay the launch of a generic version of the narcolepsy therapy Provigil (modafinil).
Mylan wins court ruling for Copaxone 40mg/mL patents pharmaceutical-technology
February 06, 2017
Global generic and specialist pharmaceuticals company Mylan has won a US District Court Ruling with regards to its Copaxone 40mg/mL patents.
Mylan acquires Cold-EEZE brand to further expand OTC business cphi-online
January 24, 2017
Cold-EEZE will become Mylan's largest US OTC brand franchise.
FDA Accepts Biologics License Application (BLA) for Mylan and Biocon's Proposed Biosimilar Trastuzum americanpharmaceuticalreview
January 13, 2017
Mylan and Biocon Ltd. have announced that the U.S. Food and Drug Administration (FDA) has accepted Mylan's biologics license application (BLA) for MYL-1401O, a proposed biosimilar trastuzumab, for filing through the 351(k) pathway. This product is a propo

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