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...
Trevena Announces Initiation of Healthy Volunteer Study for Oliceridine
June 20, 2019 07:00 ET
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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...
BeiGene Announces Acceptance of Supplemental Import Drug Application in China for ABRAXANE® in Metastatic Pancreatic Cancer
May 30, 2019 19:00 ET
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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...
BeiGene Announces Acceptance of a Supplemental New Drug Application in China for Tislelizumab in Urothelial Carcinoma
May 30, 2019 19:00 ET
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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...
IIOT-OXYS, Inc. Enters Into an Agreement with a Global Aerospace and Defense Company
May 29, 2019 08:00 ET
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IIOT-OXYS, Inc.
Cambridge, MA, May 29, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- IIOT-OXYS, Inc. (OTC Pink: ITOX) announced the execution of a Non-Disclosure Agreement (NDA) with one of the largest aerospace and...
RedHill Biopharma Submits New Drug Application for Talicia® for H. pylori Infection
May 07, 2019 06:05 ET
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RedHill Biopharma Ltd.
The NDA follows a recent positive pre-NDA meeting with the FDA The NDA for Talicia® is eligible for six-month priority review Talicia® is eligible for a total of eight years of U.S. market...
Elite Pharmaceuticals, Inc. to Host Conference Call to Discuss Year-end Financial Results on June 15, 2018
June 11, 2018 07:00 ET
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Elite Pharmaceuticals, Inc.
NORTHVALE, N.J., June 11, 2018 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the “Company") (OTCQB:ELTP), a specialty pharmaceutical company developing a pipeline of abuse-deterrent...
AGTC Files Investigational New Drug Application for the Treatment of X-linked Retinitis Pigmentosa Caused by Mutations in the RPGR Gene
August 10, 2017 07:00 ET
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Applied Genetic Technologies Corporation
GAINESVILLE, Fla., and CAMBRIDGE, Mass., Aug. 10, 2017 (GLOBE NEWSWIRE) -- Applied Genetic Technologies Corporation (NASDAQ:AGTC), a biotechnology company conducting human clinical trials of...
Agile Therapeutics Resubmits New Drug Application (NDA) for its Transdermal Contraceptive Patch, Twirla®
June 27, 2017 08:00 ET
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Agile Therapeutics, Inc.
PRINCETON, N.J., June 27, 2017 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc., (NASDAQ:AGRX), a women’s healthcare company, today announced it has resubmitted to the U.S. Food and Drug Administration...