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.

Biopharma companies announced $73.38 billion in deals from 240 transactions during the third quarter (Q3) of 2025, bringing the year-to-date total to $212.44 billion, up from $149.87 billion in the same period of 2024. The total marks the highest deal value through Q3 ever recorded by BioWorld.

Antibody-drug conjugates (ADCs) are a mature technology. The first ADC, Mylotarg, was initially approved in 2000, and there are now 14 approved agents in both leukemias and solid tumors. According to Clarivate’s Cortellis Drug Discovery & Intelligence, those drugs collectively accounted for $13.55 billion in sales in 2024 – a figure that Cortellis projects will rise to $16 billion in 2025.

The 2025 Annual Congress of the European Society for Medical Oncology (ESMO) featured a track on tumor-agnostic therapies – the first time such a track has been included at ESMO, or at any major medical oncology meeting. “It’s a milestone,” Vivek Subbiah told the audience at a session on how to accelerate tumor-agnostic drug development.

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.

Caught between the rock and the hard place of most-favored nation (MFN) pricing and the threat of a hefty biopharma sector tariff, drug companies marketing in the U.S. are exploring their options. Several large firms already have committed millions and billions of dollars in investment in new or expanded U.S.-based manufacturing facilities to avoid tariffs on finished drugs.