uniQure Announces FDA Acceptance of Biologics License Application for Etranacogene Dezaparvovec under Priority Review
May 24, 2022 08:00 ET | uniQure Inc.
LEXINGTON, Mass. and AMSTERDAM, May 24, 2022 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical...
Axsome Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for AXS-05 for Treatment of Major Depressive Disorder
April 26, 2021 06:00 ET | Axsome Therapeutics, Inc.
FDA grants Priority Review and sets PDUFA action goal date of August 22, 2021 NEW YORK, April 26, 2021 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company...
Priority Review Granted to BeiGene’s Supplemental New Drug Application in China for Tislelizumab in Urothelial Carcinoma
July 07, 2019 20:00 ET | BeiGene, LTD.
BEIJING, China and CAMBRIDGE, Mass., July 07, 2019 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and...
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Elite Announces U.S. FDA Priority Review Designation for SequestOx™ NDA
March 17, 2016 07:00 ET | Elite Pharmaceuticals, Inc.
NORTHVALE, N.J., March 17, 2016 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the “Company") (OTCBB:ELTP) today announced that the New Drug Application (NDA) for SequestOXTM...