Axsome Therapeutics Completes Successful FDA Pre-NDA Meeting for AXS-07 for the Acute Treatment of Migraine
August 20, 2020 07:00 ET
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Axsome Therapeutics, Inc.
NDA submission on track for 4Q 2020 NEW YORK, Aug. 20, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management...
Axsome Therapeutics Completes Successful FDA Pre-NDA Meeting for AXS-05 for the Treatment of Major Depressive Disorder
July 13, 2020 07:00 ET
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Axsome Therapeutics, Inc.
NDA submission on track for 4Q 2020 NEW YORK, July 13, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management...
Retrophin Announces Enrollment of First 190 Patients in Pivotal Phase 3 DUPLEX Study of Sparsentan in Focal Segmental Glomerulosclerosis
March 09, 2020 08:00 ET
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Retrophin, Inc.
SAN DIEGO, March 09, 2020 (GLOBE NEWSWIRE) -- Retrophin, Inc. (NASDAQ: RTRX) today announced that the first 190 patients have been enrolled in the pivotal Phase 3 DUPLEX Study evaluating the safety...
RespireRx Pharmaceuticals Inc. Announces Appointment of Tim Jones to its Board of Directors
February 03, 2020 09:00 ET
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RespireRX Pharmaceuticals Inc.
Glen Rock, N.J, Feb. 03, 2020 (GLOBE NEWSWIRE) -- RespireRx Pharmaceuticals Inc. (OTCQB: RSPI) (“RespireRx” or the “Company”), a leader in the research and development of cannabinoids for the...
FibroGen Submits New Drug Application to the U.S. FDA for Roxadustat in Patients With Anemia of Chronic Kidney Disease
December 23, 2019 07:00 ET
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FibroGen, Inc
SAN FRANCISCO, Dec. 23, 2019 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN), today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for...
Trevena Reports Third Quarter 2019 Results and Topline Data From Multi-Dose Healthy Volunteer QT Study
November 04, 2019 07:00 ET
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Trevena Inc.
Company expects to resubmit NDA for oliceridine in Q1 2020 Acute migraine proof-of-concept study for TRV250 initiated Company to host conference call at 8:30 a.m. EST CHESTERBROOK, Pa., Nov. 04,...
Novan Hires Michelle Patterson as Vice President of Project Management
September 03, 2019 16:05 ET
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Novan, Inc.
Underscores Company’s preparation for potential NDA submission for SB206 in molluscumRole to lead cross-functional coordination of key activities and timelines for the programSB206 top line results...
Trevena Advances NDA Resubmission Activities for Oliceridine
August 28, 2019 16:01 ET
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Trevena Inc.
— Completed enrollment in healthy volunteer QT study, topline data expected in Q4 2019 — — Completed characterization of inactive metabolite — — Remains on track to resubmit NDA in Q1 2020 — ...
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...
RedHill Biopharma Announces FDA Acceptance of New Drug Application for Talicia®
July 03, 2019 07:00 ET
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RedHill Biopharma Ltd.
U.S. FDA accepts NDA for priority review PDUFA date set for November 2, 2019 H. pylori infection affects approximately 35% of the U.S. population and is the strongest risk factor for the development...