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.
The FDA has started a review of Unicycive Therapeutics' drug for hyperphosphataemia in patients with chronic kidney disease (CKD) who need dialysis, which hopes to improve on 'onerous' phos
Johnson & Johnson has reported positive phase 3 data with Darzalex in smouldering multiple myeloma (SMM), just before filing applications for the drug in this indication in Europe and t
Disc Medicine has charted a route to market for bitopertin, its drug candidate for rare disease erythropoietic protoporphyria (EPP), after meeting with the FDA.
It has been five years since Lexicon Pharma's type 1 diabetes therapy, Zynquista, was rejected by the FDA, and it may struggle to have a better outcome at its second attempt.
