Specialty Pharma Journal Specialty, Precision & Technology
EMERYVILLE, Calif., Dec. 20, 2018 (GLOBE NEWSWIRE) — Gritstone Oncology, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing the next generation of cancer immunotherapies to fight multiple cancer types, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to GRANITE-001 for the treatment of …
Tag Archives: Fast Track designation
December, 2018
November, 2018
-
28 November
Acceleron Receives FDA Fast Track Designation for ACE-083 in Charcot-Marie-Tooth Disease
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Acceleron Pharma Inc. (NASDAQ:XLRN), a leading biopharmaceutical company in the discovery and development of TGF-beta therapeutics to treat serious and rare diseases, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation to ACE-083, the Company’s locally-acting “Myostatin+” muscle agent, for the …
-
28 November
FDA Grants Fast Track Designation to Galapagos’ Investigational Disease-Modifying Osteoarthritis Drug
Mechelen, Belgium; 27 November 2018, 22.01 CET – Galapagos NV (Euronext & NASDAQ: GLPG) announced today that the FDA has granted GLPG1972/S201086 Fast Track designation for the treatment of patients with osteoarthritis (OA). The US Food and Drug Administration’s (FDA’s) Fast Track program is designed to facilitate the development and expedite the …
-
28 November
Rocket Pharmaceuticals Receives FDA Regenerative Medicine Advanced Therapy and Fast Track Designations for RP-L102 Gene Therapy for Fanconi Anemia
NEW YORK–(BUSINESS WIRE)–Rocket Pharmaceuticals, Inc. (Nasdaq: RCKT) (“Rocket”), a leading U.S.-based multi-platform gene therapy company, today announces that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations to RP-L102, the Company’s lentiviral vector (LVV)-based gene therapy for the treatment of Fanconi Anemia …
September, 2018
-
27 September
FDA Grants Fast Track Designation to Protagonist’s Hepcidin Mimetic PTG-300
NEWARK, Calif., Sept. 27, 2018 /PRNewswire/ — Protagonist Therapeutics, Inc. (Nasdaq:PTGX) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to therapeutic candidate PTG-300 for the treatment of chronic anemia due to ineffective erythropoiesis in patients with beta-thalassemia. PTG-300 is an injectable hepcidin mimetic that has been granted Orphan Drug …
-
25 September
FDA Grants QIDP and Fast Track Designations to Cidara’s Rezafungin Prophylaxis Development Program
SAN DIEGO–(BUSINESS WIRE)–Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing novel anti-infectives including immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has granted both Qualified Infectious Disease Product (QIDP) and Fast Track designations for the company’s prophylaxis (prevention) development program for lead antifungal product candidate, rezafungin …
-
13 September
FDA Grants Fast Track Designation to ArQule’s Miransertib for the Treatment of PIK3CA-Related Overgrowth Spectrum
BURLINGTON, Mass.–(BUSINESS WIRE)–ArQule, Inc. (Nasdaq: ARQL) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to miransertib (ARQ 092) for the treatment of PIK3CA-Related Overgrowth Spectrum (PROS), a group of related, ultra-rare genetic disorders characterized by excessive tissue growth in various parts of the …
August, 2018
-
30 August
FDA Grants Insys’ Epinephrine Nasal Spray Fast Track Designation as Investigational Treatment for Anaphylaxis
PHOENIX, Aug. 30, 2018 (GLOBE NEWSWIRE) — INSYS Therapeutics, Inc. (NASDAQ: INSY), a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the company’s epinephrine nasal spray as an investigational treatment for …
-
27 August
FDA Grants Fast Track Designation to Cantex Pharmaceuticals’ Investigational CX-01 for Treatment of Acute Myeloid Leukemia
WESTON, Fla., Aug. 27, 2018 /PRNewswire/ — Cantex Pharmaceuticals, Inc., a clinical stage biopharmaceutical company developing proprietary pharmaceuticals for the treatment of cancer, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track Designation for Cantex’s lead product candidate, CX-01, for the treatment of patients over …
-
20 August
FDA Grants Fast Track Designation to Aravive Biologics’ AVB-S6-500 for Treatment of Ovarian Cancer
HOUSTON–(BUSINESS WIRE)–Aravive Biologics, Inc. announced today that the U.S. Food and Drug Administration has granted Fast Track Designation to AVB-S6-500 as a potential treatment for platinum-resistant recurrent ovarian cancer. “Gaining Fast Track Designation is an important recognition of the potential that AVB-S6-500 has to offer to meet a critical unmet …