Fortress Biotech and Cyprium Therapeutics Announce U.S. FDA Acceptance and Priority Review of NDA for CUTX-101 for Treatment of Menkes Disease
06 janv. 2025 08h00 HE
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Fortress Biotech, Inc.
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 ...
Zealand Pharma announces designation of priority review by the US FDA for dasiglucagon in congenital hyperinsulinism
30 août 2023 01h33 HE
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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
24 mai 2022 08h00 HE
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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
26 avr. 2021 06h00 HE
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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
07 juil. 2019 20h00 HE
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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
17 mars 2016 07h00 HE
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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...