The FDA has accepted the first publicly announced biosimilar filing for Keytruda, built with no comparative Phase 3 trial. The pathway shortcut, not the molecule, is what reshapes the $31.7 billion franchise.
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KRAS sat on the undruggable list for decades. Silexion's SIL204 is built to silence the mutation earlier in the cell, and the Phase 2/3 program is now moving into patients.
FDA cleared Motivista as the first authorized treatment for negative symptoms of schizophrenia, but the pivotal trial showed a small-to-moderate effect against a control arm that also improved. The open question is whether payers will cover an app.
CSL is paying $355 million upfront for an antibody whose best evidence is a 26-patient interim readout. The deal prices claudin-1 biology, not proven data, across kidney and liver fibrosis.