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The US Food and Drug Administration (FDA) has accepted French biopharmaceutical firm Genkyotex's investigational new drug (IND) application, allowing the company to initiate a Phase II trial of its GKT831 for the treatment of primary biliary cholangi…
Original Article: Genkyotex to initiate Phase II trial of GKT831 to treat PBCNEXT ARTICLE
In order to become availible to pateints, drugs need to undergo a number of phases of clinical trials to test their efficacy and safty and to then be authorised by the drug approval organistion in each respective country. This is the FDA in the USA and N...
Biopharmaceuticals are medical drugs produced using biotechnology. They include proteins (including antibodies), nucleic acids (DNA, RNA or antisense oligonucleotides) and living microorganisms like virus and bacteria where the virulance of viruses and b...