The FDA apparently deems an uncontrolled study acceptable – five months after saying no.
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Could RO7851624, newly into clinical trials, be RG6735?
Artios, Synnovation and Novartis show mere glimmers of activity.
Keynote-905 finds a 50% reduction in the risk of death in (neo)adjuvant muscle-invasive bladder cancer.
But it will be up to regulators to decide if giredestrant has done enough for an all-comers label.
Enhertu improves outcomes in (neo)adjuvant breast cancer, but toxicity resurfaces.
Alongside full PIK3CA wild-type data, Celcuity sets the bar for gedatolisib's PIK3CA-mutant readout.
Boehringer’s Hernexeos and Bayer’s sevabertinib look similar in first-line HER2-mutant NSCLC.