Syapse Announces Research Collaboration with the FDA Focused on the Regulatory Use of Real-World Evidence
August 14, 2019 06:00 ET
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Syapse
SAN FRANCISCO, Aug. 14, 2019 (GLOBE NEWSWIRE) -- Syapse and the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) have signed a multi-year Research Collaboration Agreement...
American Premium Water Corp (OTC:HIPH) Positions Itself for Opportunities in CBD Sector in Advance of FDA Guidance on CBD
August 01, 2019 08:30 ET
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American Premium Water Co.
PLAYA VISTA, CA, Aug. 01, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- American Premium Water Corporation (OTC: HIPH) (“the Company”) announces that as the Food and Drug Administration (FDA)...
Yhdysvaltain lääkeviranomainen FDA on myöntänyt myyntiluvan darolutamidille, joka on uusi lääke etäpesäkkeettömän, kastraatioresistentin eturauhassyövän (nmCRPC) hoitoon
July 31, 2019 00:30 ET
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Orion Oyj
ORION OYJ LEHDISTÖTIEDOTE 31.7.2019 klo 7.30 Yhdysvaltain lääkeviranomainen FDA on myöntänyt myyntiluvan darolutamidille, joka on uusi lääke etäpesäkkeettömän,...
U.S. FDA approves darolutamide, a new treatment for men with non-metastatic castration-resistant prostate cancer (nmCRPC)
July 31, 2019 00:30 ET
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Orion Oyj
ORION CORPORATION PRESS RELEASE 31 JULY 2019 at 7.30 EEST U.S. FDA approves darolutamide, a new treatment for men with non-metastatic castration-resistant prostate cancer...
Abeona Therapeutics Announces Positive Interim Data from the ABO-102 Phase 1/2 Gene Therapy Clinical Trial in MPS IIIA
July 25, 2019 09:15 ET
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Abeona Therapeutics Inc.
Neurocognitive development of youngest patients preserved 12-18 months post treatment; development scores remain within range of unaffected children Robust and sustained biomarker improvement across...
Capricor Therapeutics Announces Positive DSMB Safety and Futility Review and Continuation of its HOPE-2 Study in Duchenne Muscular Dystrophy
July 25, 2019 07:00 ET
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Capricor Therapeutics, Inc.
--Independent Data Safety Monitoring Board recommends to continue HOPE-2 study-- --Capricor to resume treating currently enrolled patients-- LOS ANGELES, July 25, 2019 (GLOBE NEWSWIRE) -- Capricor...
RAPS Publishes Updated Fundamentals of US Regulatory Affairs Book
July 17, 2019 11:42 ET
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Regulatory Affairs Professionals Society (RAPS)
Rockville, MD, USA, July 17, 2019 (GLOBE NEWSWIRE) -- The Regulatory Affairs Professionals Society (RAPS) has just published the updated, 11th edition of Fundamentals of US Regulatory Affairs, the...
Capricor Therapeutics Announces Positive Results from its Interim Analysis in the HOPE-2 Trial to Treat Patients with Duchenne Muscular Dystrophy
July 15, 2019 06:00 ET
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Capricor Therapeutics, Inc.
--Interim Analysis Showed Statistically Significant Improvements in the Performance of the Upper Limb, Grip Strength and Inspiratory Flow Reserve in the Randomized Double-Blind Placebo Controlled...
Public-Private Summit Convenes in New Orleans to Comprehensively Address Challenges in Domestic Shrimp Industry
July 10, 2019 15:54 ET
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American Shrimp Processors Association
NEW ORLEANS, July 10, 2019 (GLOBE NEWSWIRE) -- Members of the American Shrimp Processors Association (ASPA) participated in an industry summit on July 9, 2019 at the U.S. Customs House in New...
Growth in Rare Disease R&D Is Challenging Development Strategy and Execution, According to Tufts Center for the Study of Drug Development
July 09, 2019 09:00 ET
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Tufts Center for the Study of Drug Development
BOSTON, July 09, 2019 (GLOBE NEWSWIRE) -- Rare disease drug development, which now accounts for nearly one-third of all drugs in active R&D worldwide, presents scientific and operational...