Specialty Pharma Journal Specialty, Precision & Technology
WALTHAM, Mass.–(BUSINESS WIRE)–ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its lead program, mirvetuximab soravtansine. The designation is for the treatment of patients with …
Tag Archives: Fast Track
June, 2018
May, 2018
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3 May
FDA Grants Fast Track Status to Regenxbio’s Investigational Gene Therapy for Treatment of MPS II
ROCKVILLE, Md., May 2, 2018 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for …
April, 2018
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25 April
FDA Grants Fast Track Status to Synlogic’s Investigational Phenylketonuria Therapy
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Synlogic (Nasdaq: SYBX), a clinical-stage company applying synthetic biology to probiotic bacteria to develop novel living medicines, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its clinical product candidate, SYNB1618. SYNB1618 is an oral, investigational medicine designed to metabolize phenylalanine as …
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23 April
FDA Grants Fast Track Status to MeiraGTx’s AAV-RPGR for the Treatment of X-Linked Retinitis Pigmentosa Due to RPGR Deficiency
LONDON & NEW YORK–(BUSINESS WIRE)–MeiraGTx Limited, a vertically integrated, clinical stage gene therapy company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for AAV-RPGR for the treatment of X-linked retinitis pigmentosa (XLRP) due to defects in the retinitis pigmentosa GTPase regulator (RPGR) gene. “XLRP …
December, 2017
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26 December
FDA Grants Fast Track Designation to DelMar’s Recurrent Glioblastoma Candidate
VANCOUVER, British Columbia and MENLO PARK, Calif., Dec. 26, 2017 /PRNewswire/ — DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) (“DelMar” or the “Company”), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for …
May, 2017
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17 May
Sangamo’s Hemophilia A Gene Therapy Candidate Receives Fast Track Status from the FDA
RICHMOND, Calif., May 16, 2017 /PRNewswire/ — Sangamo Therapeutics, Inc. (NASDAQ: SGMO) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to SB-525, the Company’s clinical stage cDNA gene therapy candidate for hemophilia A, which is being developed as part of an exclusive, global …
March, 2017
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22 March
Shire’s Hereditary Thrombotic Thrombocytopenic Purpura Treatment Receives Fast Track Status from the FDA
Lexington, Mass. – March 22, 2017 – Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation for recombinant ADAMTS13 (SHP655 – historically known as BAX930) for treatment of acute episodes of hereditary thrombotic thrombocytopenic purpura (hTTP) in …
September, 2016
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2 September
Biogen’s Alzheimer’s Disease Candidate Gains Fast Track Status from the FDA
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Today Biogen (NASDAQ: BIIB) announced that aducanumab, its investigational treatment for early Alzheimer’s disease (AD), was granted Fast Track designation by the U.S. Food and Drug Administration (FDA). The FDA’s Fast Track program supports the development of new treatments for serious conditions with an unmet medical need such as Alzheimer’s …
February, 2016
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3 February
FDA Grants Fast Track Status to TapImmune’s Lead Ovarian Cancer Vaccine
TapImmune, Inc. (TPIV), a clinical-stage immuno-oncology company specializing in the development of innovative peptide and gene-based immunotherapeutics and vaccines for the treatment of cancer & metastatic disease, announced today that the U.S. Food & Drug Administration (FDA) has granted Fast Track Designation for its cancer vaccine TPIV 200 in the …
December, 2015
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11 December
Cardiorentis’ ADHF Drug Receives Fast Track Status from the FDA
ZUG, Switzerland, Dec. 11, 2015 /PRNewswire/ — Cardiorentis AG, a privately held biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track status to Ularitide, an investigational therapy for the treatment of acute decompensated heart failure (ADHF). The FDA’s Fast Track process is intended …