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A Karyopharm Therapeutics multiple myeloma drug candidate faces longer odds for speedy FDA approval after the agency’s staff raised questions about the therapy’s efficacy and safety. Staff concerns about Karyopharm drug selinexor were detailed in briefing documents posted Friday afternoon, ahead of an advisory committee meeting scheduled for Tuesday. Such panels are convened to assess […]
Original Article: FDA Staff Hammers Karyopharm Cancer Drug on Safety, Efficacy ConcernsNEXT ARTICLE
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...
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...