Ten years after the first biosimilar launched on the U.S. market, the FDA is taking steps to make biosimilar development and pharmacy substitution more like that of generics, reducing the cost of the drugs in the process. “We want to see more biosimilars. We want to see more competition,” FDA Commissioner Marty Makary said at an Oct. 29 media briefing in which he announced new guidance to streamline biosimilar development, cut through the red tape and shorten the timeline.

Exousia Pro Inc.’s subsidiary, Exousia AI, has received orphan drug designation from the FDA for its exosome-based treatment for malignant glioma.

Resolute Science Inc.’s RS-5 has been awarded orphan drug designation by the FDA for the treatment of soft tissue sarcomas.

Takeda Pharmaceutical Co. Ltd. agreed to codevelop and commercialize up to three of Innovent Biologics Co. Ltd.’s immuno-oncology (I-O) and antibody-drug conjugate (ADC) candidates with the signing of a $11.4 billion deal, including $1.2 billion paid up front.

Dewpoint Therapeutics Inc. has announced an IND in the U.S. for DPTX-3186, a first-in-class oral condensate modulator designed to selectively disrupt oncogenic Wnt/β-catenin signaling in tumors. Dosing is set to begin before year-end in a phase I/II trial conducted in partnership with cancer centers and opinion leaders in gastric and other Wnt-driven cancers.

San Diego-based Dexcom Inc., is the target of a class action lawsuit in U.S. district court over the company’s G7 continuous glucose monitors, an action which follows a U.S. FDA warning letter by a mere seven months and a recall announced in July, suggesting that litigation often follows other sources of bad news for firms in the med-tech business.

Sweeping “radical” changes in both the U.S. FDA and China’s drug development landscape are keeping the global life science industry on its toes in assessing what’s temporary and what’s not, speakers said at the Bioplus Interphex (BIX) Korea 2025 conference in Seoul, South Korea, on Oct. 15.

The U.K. Medicines and Healthcare Products Regulatory Agency reported the winners of the second phase of the AI Airlock challenge, which includes the Tortus AI, a medical scribe system developed by physicians in the U.K. National Health Service.

The U.S. FDA approved 17 drugs in September 2025, following 18 approvals in August and 17 in July. That brings the year-to-date total to 160 approvals for the first three quarters, making it the second-highest total on record for this period, behind 183 approvals logged during the same timeframe in 2024.