Equillium Granted U.S. FDA Orphan Drug Designations for EQ001 (itolizumab) for both the Prevention and Treatment of Acute Graft-Versus-Host Disease
February 07, 2019 08:08 ET
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Equillium
LA JOLLA, Calif., Feb. 07, 2019 (GLOBE NEWSWIRE) -- Equillium, Inc. (Nasdaq: EQ), a biotechnology company developing treatments for severe immuno-inflammatory disorders, today announced that the...
PledPharma har ansökt om särläkemedelsstatus (ODD) för Aladote i USA
December 24, 2018 02:00 ET
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PledPharma AB
Stockholm, 24 december 2018. PledPharma AB (publ) meddelar att bolaget har lämnat in en ansökan till amerikanska läkemedelsmyndigheten FDA om särläkemedelsstatus (ODD, Orphan Drug Designation) för...
PledPharma applies for an Orphan Drug Designation (ODD) in the US for Aladote
December 24, 2018 02:00 ET
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PledPharma AB
Stockholm, December 24, 2018. PledPharma AB (publ) announces that the company has filed an application for an Orphan Drug Designation (ODD) to the US FDA for the drug candidate Aladote®, developed to...
Akari Therapeutics Announces FDA Allowance of IND for Clinical Development of Coversin in PNH
January 03, 2017 07:00 ET
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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...
Protalix BioTherapeutics Receives Letter Detailing Intended Purchases of Approximately $24 Million of alfataliglicerase to Treat Gaucher Patients in Brazil
December 14, 2016 07:30 ET
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Protalix BioTherapeutics, Inc.
CARMIEL, Israel, Dec. 14, 2016 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX) (the “Company”) announced today that the Company received a letter from Fundação Oswaldo...
Akari Therapeutics Announces Corporate Update with New Positive Clinical Data and a New Pipeline of Tick Derived and Engineered Proteins
December 05, 2016 07:00 ET
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Akari Therapeutics, Plc
-Phase Ib cohorts demonstrate dose effect and additional support for once daily dosing--PAS-Coversin pre-clinical data supports once weekly dosing--Phase II PNH patients identified with data expected...
Akari Therapeutics Announces Receipt of Orphan Drug Designation for Coversin from the U.S. FDA for Treatment of Paroxysmal Nocturnal Hemoglobinuria
September 12, 2016 07:15 ET
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Akari Therapeutics, Plc
NEW YORK and LONDON, Sept. 12, 2016 (GLOBE NEWSWIRE) -- Akari Therapeutics (NASDAQ:AKTX), an emerging growth, development-stage biopharmaceutical company, announced today that the U.S. Food and...
Akari Therapeutics Receives Approval from the UK Medicines & Healthcare Products Regulatory Agency to Conduct Phase 2 Trial in Paroxysmal Nocturnal Hemoglobinuria
July 13, 2016 07:00 ET
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Akari Therapeutics, Plc
NEW YORK and LONDON, July 13, 2016 (GLOBE NEWSWIRE) -- Akari Therapeutics (NASDAQ:AKTX), an emerging growth, clinical-stage biopharmaceutical company, announced today the approval by the UK...
XOMA Initiates Phase 2 Proof-of-Concept Study of XOMA 213
June 28, 2016 09:01 ET
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XOMA Corporation
BERKELEY, Calif., June 28, 2016 (GLOBE NEWSWIRE) -- XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced today it has initiated its Phase...
Akari Therapeutics Receives Positive Opinion for Orphan Drug Designation for Coversin in the European Union for Treatment of Guillain Barré Syndrome
May 23, 2016 07:10 ET
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Akari Therapeutics Plc
NEW YORK and LONDON, May 23, 2016 (GLOBE NEWSWIRE) -- Akari Therapeutics (NASDAQ:AKTX), an emerging growth, clinical-stage biopharmaceutical company, announced today that the European Medicines...