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TXT 56 Lots of Homeopathic Drug Products Recalled [88 Words] [ Price : $8.95]
Terra-Medica recalls 56 lots of Pleo-Fort, Pleo-Quent, Pleo-Not, Pleo-Stolo, Pleo-Nota-Quent, and Pleo-EX homeopathic drug products.
03/21/2014
 
 
TXT FDA Approves New Use for Novartisís Xolair [160 Words] [ Price : $8.95]
FDA approves a Novartis supplemental BLA for Xolair (omalizumab) for treating chronic idiopathic urticaria.
03/21/2014
 
 
TXT Proposal on Administrative Order Device Classifications [321 Words] [ Price : $8.95]
A new CDRH proposed rule seeks to implement FDA Safety and Innovation Act (FDASIA) provisions that allow for reclassification of devices by administrative order instead of by regulation.
03/21/2014
 
 
TXT FDA Partial Hold on Geron Myelofibrosis Trial [177 Words] [ Price : $8.95]
FDA places on partial clinical hold a Geron clinical trial of imetelstat in myelofibrosis due to hepatotoxicity concerns.
03/20/2014
 
 
TXT Janssen Ends Schizophrenia Drug Trial on Positive Results [257 Words] [ Price : $8.95]
Janssen says an independent data monitoring board recommended early termination of a clinical study of a three-month formulation of paliperidone palmitate in treating schizophrenia based on positive efficacy.
03/20/2014
 
 
TXT Experts Propose New E2E Clinical Trial Model [403 Words] [ Price : $8.95]
Experts convened by Tufts University suggest a new approach to drug clinical trials that moves seamlessly from efficacy to effectiveness studies.
03/20/2014
 
 
TXT FDA Approves New Cochlear Hearing Implant [348 Words] [ Price : $8.95]
FDA approves a Cochlear PMA for the first implantable device for people 18 and older with severe or profound sensorineural hearing loss of high-frequency sounds in both ears, but who can still hear low-frequency sounds with or without a hearing aid.
03/20/2014
 
 
TXT FDA OKs Piramal Imagingís Neuraceq for PET Imaging [143 Words] [ Price : $8.95]
FDA approves Piramal Imagingís Neuraceq for Positron Emission Tomography imaging of the brain for Alzheimerís disease evaluation.
03/20/2014
 
 
TXT FDA Approves Impavido for Treating Leishmaniasis [299 Words] [ Price : $8.95]
FDA approves Paladinís Impavido for treating the tropical disease leishmaniasis.
03/20/2014
 
 
TXT FDA Withdraws NADA, 2 ANADAs [63 Words] [ Price : $8.95]
Federal Register Notice: FDA withdraws approval of one NADA and two ANADAs for Type A medicated articles containing chlortetracycline, sulfathiazole, and penicillin because they are no longer marketed.
03/20/2014
 
 
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