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The FDA’s Allergenic Products Advisory Committee voted 7-2 in favor of supporting the efficacy profile of Palforzia, or AR101. Some committee members expressed concerns about a lack of diversity in the Phase III clinical trial.
Original Article: FDA expert panel gives thumbs-up to Aimmune’s peanut allergy drugNEXT 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...
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
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...