The FDA has rejected Citius Pharmaceuticals' marketing application for Lymphir, an updated version of a lymphoma therapy withdrawn from sale several years ago.
AstraZeneca and Daiichi Sankyo's chances of getting approval for Enhertu as a therapy for all HER2-positive tumours – regardless of their location in the body – have just
MSD & Co and Moderna have advanced a combination of an mRNA-based cancer vaccine and checkpoint inhibitor Keytruda into a phase 3 trial in skin cancer melanoma, althou
Gilead Sciences has said it will stop the development of its cancer antibody magrolimab in blood cancer myelodysplastic syndromes (MDS) after disappointing results in a ph
Mirati Therapeutics’ hopes of an EU approval for its KRAS inhibitor Krazati in the EU have been thrown into disarray after the EMA’s human medicines committee rejected the
Bavarian Nordic is preparing to file for regulatory approval of a vaccine against chikungunya virus after its CHIKV VLP candidate showed protective efficacy in a second ph
To improve trial recruitment, engagement, and retention, and to increase the likelihood that trials reflect what matters most to patients, regulatory authorities increasingly point to metho