Tag: approval

Race Oncology is pleased to announce that it has received a letter from the FDA advising that Bisantrene has been granted Rare Paediatric Disease (RPD) designation for the treatment of childhood Acute Myeloid Leukaemia (AML). The RPD designation means Bisantrene has…

Race Oncology is pleased to announce that approval has been received from the Medicines and Healthcare products Regulatory Agency (MHRA) for importation and distribution of Bisantrene as an unlicensed medicine in the UK. The letter from the MHRA was received…

Race Oncology’s second Bisantrene patent has received “Notice of Allowance” in the US. Once ‘allowed’ in a jurisdiction, a patent can proceed to a ‘granted’ patent. The patent titled, “Compositions to Improve the Therapeutic Benefit of Bisantrene and Analogs and…