The U.S. FDA gave the thumbs up to Kura Oncology Inc./Kyowa Kirin Co. Ltd.’s selective oral menin inhibitor, ziftomenib, to treat relapsed, refractory (r/r) nucleophosmin1 (NMP1)-mutant acute myeloid leukemia (AML). The approval of the drug, branded Komzifti, came more than two weeks ahead of the Nov. 30 PDUFA date.

ABL Bio Inc. inked a license and research agreement with Eli Lilly and Co. worth up to $2.6 billion to develop multiple therapeutics using the Grabody-B platform. Under the terms announced Nov. 12, ABL will receive a $40 million up-front payment and up to $2.56 billion in development, regulatory and commercialization milestones, plus tiered royalties on net sales.

Up to 77% of patients with non-small-cell lung cancer in Asia-Pacific rely almost entirely on their physicians to decide their treatment, even though 69% of physicians say they encourage shared decision-making. That disconnect remains one of the region’s biggest obstacles to improving outcomes, Anthony Elgamal, vice president of Oncology Asia Pacific at Johnson & Johnson Innovative Medicine, told BioWorld.

ABL Bio Inc. inked a license and research agreement with Eli Lilly and Co. worth up to $2.6 billion to develop multiple therapeutics using the Grabody-B platform. Under the terms announced Nov. 12, ABL will receive a $40 million up-front payment and up to $2.56 billion in development, regulatory and commercialization milestones, plus tiered royalties on net sales.

Australia’s Therapeutic Goods Administration has made a few adjustments to its advertising guidelines for social media promotions, including the requirement that the manufacturer is responsible for anything posted by influencers who are acting on behalf of the manufacturer.

A four-way interagency initiative in South Korea, started in 2020, is working to bolster funding for the local medical device industry and grow homegrown devices for the global market.

Med-tech financings with disclosed valuations from January through October 2025 totaled $26.58 billion, nearly matching 2022’s $26.83 billion and marking a continued recovery from the sector’s 2023 low of $15.59 billion. The data suggest renewed investor confidence in med-tech, with capital flows shifting back toward public markets after two years of restrained activity.

Signet Therapeutics founder Haisheng Zhang is betting on organoids and AI to outsmart diffuse gastric cancer and the limits of traditional “clean” drug design.

Takeda Pharmaceutical Co. Ltd.’s anti-CD38 antibody, mezagitamab (TAK-079), sustained kidney function up to 18 months after treatment ended in patients with primary immunoglobulin A (IgA) nephropathy, showing early signs of disease modification in a phase Ib study presented at the American Society of Nephrology’s Kidney Week 2025 in Houston.