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January 06, 2025 08:00 ET | Source: Fortress Biotech, Inc.

Fortress Biotech and Cyprium Therapeutics Announce U.S. FDA Acceptance and Priority Review of NDA for CUTX-101 for Treatment of Menkes Disease

Priority review granted for CUTX-101 with PDUFA target action date set for June 30, 2025 Cyprium is eligible to receive royalties and up to $129 million in aggregate development and sales milestones ...
August 30, 2023 01:33 ET | Source: Zealand Pharma

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...
May 24, 2022 08:00 ET | Source: uniQure Inc.

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...
April 26, 2021 06:00 ET | Source: Axsome Therapeutics, Inc.

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...
July 07, 2019 20:00 ET | Source: BeiGene, LTD.

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...
March 17, 2016 07:00 ET | Source: Elite Pharmaceuticals, Inc.

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...