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Novartis has received approval for its CAR-T treatment of paediatric and young adults with a form of acute lymphoblastic leukaemia (ALL). The approval marks a breakthrough for this type of treatment that reengineers the body’s own immune system to combat cancer and had the FDA referencing its decision as ‘historic’.
It was an approval that was widely expected, after an FDA advisory committee gave the drug the thumbs up but the decision has been arrived at sooner than expected. It means hundreds of patients could be eligible for the treatment immediately.
Original Article: CAR-T treatment is given ‘historic’ first approval by FDANEXT ARTICLE
The Top 100 Pharmaceutical Companies
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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...