Zealand Pharma announces designation of priority review by the US FDA for dasiglucagon in congenital hyperinsulinism
August 30, 2023 01:33 ET
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Zealand Pharma
Company announcement – No. 31 / 2023 Zealand Pharma announces designation of priority review by the US FDA for dasiglucagon in congenital hyperinsulinism US FDA has granted priority review...
uniQure Announces FDA Acceptance of Biologics License Application for Etranacogene Dezaparvovec under Priority Review
May 24, 2022 08:00 ET
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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
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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
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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...
Elite Announces U.S. FDA Priority Review Designation for SequestOx™ NDA
March 17, 2016 07:00 ET
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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...