FDA accepts resubmission of Replimune’s RP1 cancer therapy, decision due Aug. 2; Merck KGaA announces $11 B life-sciences spend

The U.S. Food and Drug Administration has accepted Replimune's resubmitted application for its cancer drug RP1, with a final decision slated for August 2 and an advisory committee meeting planned for July.

The acceptance is seen as part of a broader shift in the agency's approach after criticism of earlier leadership for inconsistent feedback that led to delays and rejections for several companies.

Revolution Medicines shared Phase 2 results for its second RAS‑blocking candidate, zoldonrasib, indicating tumor shrinkage or elimination in pancreatic cancer patients when used alongside chemotherapy.

Definium Therapeutics completed a stock offering that raised $800 million, while Merck KGaA disclosed an $11 billion investment in life‑sciences services.