A few days after a disappointing clinical trial readout for Syndax Pharma's Revuforj in one form of leukaemia, the company has claimed FDA approval in another.
More than two years after its approval in Europe, PTC Therapeutics' gene therapy for rare genetic disorder AADC deficiency will soon be made available to patients in the US.
Nine months after filing their TROP2-directed antibody-drug conjugate Dato-DXd for a lung cancer indication with the FDA, Daiichi Sankyo and AstraZeneca have pulled the submission.