FDA has granted accelerated approval to Ultomiris based on Phase III data showing a 43.4% placebo-adjusted reduction at 34 weeks.

Median net launch prices for new drugs climbed between 2022 and 2025 to $257,000, according to a new ICER and West Health report that also found persistent coverage and access barriers for patients.

FDA approved an at-home induction option for risankizumab-rzaa in adults with moderate-to-severe Crohn's disease, based on the phase 3 AFFIRM trial.

Treasury proposes adding biotechnology to its Outbound Investment Security Program, a pharma funding roundup covers Gilead’s $1.275 billion acquisition of an oral IL-23R inhibitor from PepStar and Zymeworks’ licensing deal with Roche, and Incubate’s John Stanford on why MFN is an offer pharma can’t refuse.

Dave Maraldo, Ph.D., president of manufacturing at Merck, explains how flexible capacity, earlier input from manufacturing in R&D, and digital tools are helping the organization keep up with a faster, more varied portfolio.

The Treasury Department is proposing rules to add biotechnology to its Outbound Investment Security Program under the COINS Act.

Gilead agrees to acquire an oral IL-23R inhibitor from PepStar, while Zymeworks licenses its DLL3-targeting T cell engager ZW209 to Roche.

Incubate’s John Stanford on why MFN is voluntary in name only — and why the moonshot is the first casualty of drug pricing pressure.