Orphazyme assumes sp
Orphazyme assumes sponsorship of Phase II/III sIBM trial
December 15, 2017 09:20 ET | ORPHAZYME A/S
Investor newsNo. 01/2017 Orphazyme assumes sponsorship of Phase II/III sIBM trial On December 14, 2017, Orphazyme A/S, University of Kansas Medical Center, and UCL announced that Orphazyme...
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AXIM Biotech Announces Successful Completion of Pre-IND Meeting with FDA on Comparable Product to Marinol; Green Light from FDA for IND Submission
December 12, 2017 09:00 ET | AXIM BIOTECHNOLOGIES, INC
NEW YORK, Dec. 12, 2017 (GLOBE NEWSWIRE) -- AXIM® Biotechnologies, Inc. (OTC:AXIM), a world leader in cannabinoid research and development, announced today that it has successfully completed a...
2X Oncology Obtains
2X Oncology Obtains Investigational New Drug Application for 2X-111 Glutathione Enhanced PEGylated Liposomal Doxorubicin
June 08, 2017 09:06 ET | 2X Oncology, Inc.
CAMBRIDGE, Mass., June 08, 2017 (GLOBE NEWSWIRE) -- 2X Oncology, Inc. ("2X" or the "Company"), a precision medicine company developing targeted therapeutics to address significant unmet needs in...
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TESARO Announces Submission of Investigational New Drug Application for Anti-LAG Antibody TSR-033 to the U.S. FDA
May 01, 2017 08:30 ET | TESARO, Inc.
WALTHAM, Mass., May 01, 2017 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced the submission of an Investigational New Drug (IND)...
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Akari Therapeutics Announces FDA Allowance of IND for Clinical Development of Coversin in PNH
January 03, 2017 07:00 ET | Akari Therapeutics, Plc
NEW YORK and LONDON, Jan. 03, 2017 (GLOBE NEWSWIRE) -- Akari Therapeutics (NASDAQ:AKTX), an emerging growth, clinical-stage biopharmaceutical company, announced today that the U.S. Food and Drug...
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Axsome Therapeutics Receives FDA Clearance of IND for Phase 2/3 Trial of AXS-05 in Alzheimer’s Disease Agitation
January 03, 2017 07:00 ET | Axsome Therapeutics, Inc.
NEW YORK, Jan. 03, 2017 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous...
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Fate Therapeutics Announces FDA Clearance of Investigational New Drug Application for ProTmune for Prevention of Acute GvHD and CMV Infection
January 26, 2016 16:36 ET | Fate Therapeutics, Inc.
SAN DIEGO, Jan. 26, 2016 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ:FATE), a biopharmaceutical company dedicated to the development of programmed cellular immunotherapeutics for cancer...
China Food and Drug
China Food and Drug Administration Accepts IND for Pivotal Study of AMITIZA(R) (lubiprostone)
June 15, 2015 16:02 ET | Sucampo Pharmaceuticals Inc
BETHESDA, Md., June 15, 2015 (GLOBE NEWSWIRE) -- Sucampo Pharmaceuticals, Inc. (Sucampo) (Nasdaq:SCMP), a global pharmaceutical company, today announced that the China Food and Drug Administration...
FDA Grants Fast Trac
FDA Grants Fast Track Designation to Sucampo's Cobiprostone for Oral Mucositis
May 07, 2015 16:42 ET | Sucampo Pharmaceuticals Inc
BETHESDA, Md., May 7, 2015 (GLOBE NEWSWIRE) -- Sucampo Pharmaceuticals, Inc. (Sucampo) (Nasdaq:SCMP), a global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA)...
FDA Authorizes New Hemispherx Biopharma Clinical Trial of Intranasal Ampligen(R) With Seasonal Influenza Vaccine
July 20, 2011 08:00 ET | Hemispherx Biopharma, Inc.
PHILADELPHIA, July 20, 2011 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the "Company" or "Hemispherx") today announced it has received U.S. Food Drug Administration (FDA)...