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.
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.
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.
While the pace of executive orders (EOs) coming out of the White House has slowed, the Trump administration is still churning them out. As of the end of the third quarter, President Donald Trump had issued 209 EOs. Of those, BioWorld tracked 37 that directly impact drug and device R&D, regulatory burdens, pricing and market competition.
Biopharma dealmaking was up 32% month over month in September, reaching $27.15 billion in total value, up from $20.52 billion in August. It was the fourth-highest month for deals of the year, which through the month average $23.6 billion a month. Year-to-date deal value (January through September) reached $212.44 billion, surpassing the nine-month totals of all previous years.
Japan’s investor community is ramping up both inbound and outbound investment to create a cross-border fertile hub of innovation in Japan, investors said during a panel discussion at Bio Japan 2025 held in Yokohama Oct. 8 to 10.
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