New approvals in the US and EU, label expansions and commercial launches.
Protagonist Therapeutics says the FDA's August approval of rusfertide for polycythemia vera drove milestone income, while icotrokinra gained approvals in China, Japan and the EU.
Armenia's Ministry of Health has authorised Botvymo and Evamplix for previously treated MSS metastatic colorectal cancer, as Agenus reports Q3 2026 results and readies its Phase 3 ROBBIN trial.
The US regulator has accepted Zenas BioPharma's biologics licence application, while the EMA has validated the company's European marketing authorisation application for the same indication.
The US regulator has accepted Palvella's application and set a PDUFA action date of 28 February 2027, with a standalone launch planned for the first half of 2027 if approved.
Summit Therapeutics says the FDA has set a 14 November 2026 PDUFA date for ivonescimab in EGFR-mutated NSCLC, with the regulator requiring statistically significant overall survival.