Tag Archives: Orphan Drugs

August, 2017

July, 2017

June, 2017

  • 29 June

    FDA Unveils Plan to Eliminate Orphan Designation Backlog

    Today, the U.S. Food and Drug Administration unveiled a strategic plan to eliminate the agency’s existing orphan designation request backlog and ensure continued timely response to all new requests for designation with firm deadlines. The agency’s Orphan Drug Modernization Plan comes a week after FDA Commissioner Scott Gottlieb committed to …

December, 2016

November, 2016

October, 2016

August, 2016

  • 19 August

    Zymeworks Receives Orphan Status from the FDA for Two of its Ovarian Cancer Drugs

    VANCOUVER, British Columbia–(BUSINESS WIRE)–Zymeworks Inc., a biopharmaceutical company discovering and developing innovative multi-functional protein-based therapeutics, including bi-specific antibodies and drug conjugates for the treatment of cancer, announced today that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation to Zymeworks’ lead investigational products ZW25 and ZW33 …

February, 2016

May, 2015

  • 28 May

    Cerulean Pharma’s Ovarian Cancer Drug Granted Orphan Drug Status

    The US Food and Drug Administration (FDA) has granted Orphan Drug designation to Cerulean Pharma Inc.’s investigational ovarian cancer drug. The company announced that the agency granted the designation to its nanoparticle-drug conjugate (NDC), CRLX101, for the treatment of patients with ovarian cancer. The designation provides certain incentives, such as …