Alnylam Pharmaceuticals, a RNAi therapeutics company, announced that the US Food and Drug Administration (FDA) has granted fast track designation to patisiran (ALN-TTR02) for the treatment of transthyretin (TTR)-familial amyloid ...
Tags: Alnylam, Fast Track Designation
Clinical-stage pharmaceutical company Adynxx has obtained the US Food and Drug Administration (FDA) fast track designation for its AYX1 injection, which is used for prevention of chronic pain. In a five-cohort, dose-escalating study ...
Sanofi Pasteur and KaloBios Pharmaceuticals have announced the issuance of FDA fast track designation for novel biologic candidate KB001A targetting Pseudomonas Aeruginosa (Pa). An antibody fragment KB001A is developed against Pa that ...
Tags: Sanofi Pasteur, KB001A
Biotechnology company Genmab has obtained FDA fast track designation in double refractory multiple myeloma for daratumumab. As per the designation, the human CD38 monoclonal antibody Daratumumab is suitable for multiple myeloma patients ...
TransTech Pharma has received FDA fast track designation for new small-molecule chemical compound TTP488, for the treatment of Alzheimer's disease. TTP488 prevents interaction of a material found in the Alzheimer's patients cells, ...
Tags: Transtech Alzheimer, FDA, Medicine
Chimerix, a US-based company which discovers, develops and commercializes oral antiviral therapeutics, has won the US Food and Drug Administration (FDA) fast track designation for CMX001 for the prevention of cytomegalovirus (CMV) ...
Tags: Chimerix, oral antiviral therapeutics, FDA, CMX001
The US FDA has granted Soligenix fast track designation for OrbeShield for the reduction of mortality associated with gastrointestinal acute radiation syndrome (GI ARS). The oral beclomethasone 17,21-dipropionate (oral BDP) earlier ...
Tags: US FDA, Soligenix, fast track designation, OrbeShield
Isis Pharmaceuticals has obtained the US FDA fast track designation for ISIS-TTR to treat familial amyloid polyneuropathy (FAP). The antisense drug ISIS-TTR, a part of the Isis-GSK strategic RNA therapeutic alliance, is being developed ...
Tags: amyloid polyneuropathy candidate, Pharmaceuticals, genetic disease, drug
Tokai Pharmaceuticals has gained FDA fast track designation for galeterone (TOK-001) for the potential treatment of metastatic castration-resistant prostate cancer (CRPC). Galeterone disrupts androgen receptor (AR) signaling, the key ...
Tags: galeterone, TOK-001, castration-resistant prostate cancer, CRPC
XBiotech has received FDA fast track designation for its anti-cachexia drug Xilonix, a first-in-class True Human antibody. Xilonix blocks an inflammatory substance (IL-1a) produced by the body in response to tumor growth, which plays a ...
The FDA has granted fast track designation for Achillion Pharmaceuticals' ACH-3102 as part of an interferon-free regimen for the treatment of chronic hepatitis C (HCV). ACH-3102 is a pan-genotypic second-generation NS5A inhibitor ...
Tags: FDA Fast Track Designation, chronic hepatitis C, pharmaceutical product
EpiCept has received fast track designation for AmiKet (amitriptyline 4%, ketamine 2% cream) from the US Food and Drug Administration (FDA). AmiKet is indicated for the treatment of neuropathic pain associated with ...
Tags: FDA, fast track designation, treatment of neuropathic pain