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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 | 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...
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RespireRx Pharmaceuticals Inc. Announces Appointment of Tim Jones to its Board of Directors
February 03, 2020 09:00 ET | 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...
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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 | 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...
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Trevena Reports Third Quarter 2019 Results and Topline Data From Multi-Dose Healthy Volunteer QT Study
November 04, 2019 07:00 ET | 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,...
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Novan Hires Michelle Patterson as Vice President of Project Management
September 03, 2019 16:05 ET | 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...
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Trevena Advances NDA Resubmission Activities for Oliceridine
August 28, 2019 16:01 ET | 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 — ...
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Priority Review Granted to BeiGene’s Supplemental New Drug Application in China for Tislelizumab in Urothelial Carcinoma
July 07, 2019 20:00 ET | 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...
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RedHill Biopharma Announces FDA Acceptance of New Drug Application for Talicia®
July 03, 2019 07:00 ET | 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...
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Trevena Announces Initiation of Healthy Volunteer Study for Oliceridine
June 20, 2019 07:00 ET | Trevena Inc.
CHESTERBROOK, Pa., June 20, 2019 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN) (“Trevena” or the “Company”), a biopharmaceutical company focused on the development and commercialization of novel...
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BeiGene Announces Acceptance of Supplemental Import Drug Application in China for ABRAXANE® in Metastatic Pancreatic Cancer
May 30, 2019 19:00 ET | BeiGene, LTD.
CAMBRIDGE, Mass. and BEIJING, China, May 30, 2019 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and...