Zealand Pharma announces designation of priority review by the US FDA for dasiglucagon in congenital hyperinsulinism 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 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 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 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 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...