The U.S. FDA approved 27 drugs in December, the highest month of 2025. This compares to 18 approvals in November and brings the full year total to 226. This places 2025 just below the 228 approvals recorded in 2024 but well above approval numbers seen in most prior years of the past decade.
Despite pressure on drug pricing, an ongoing threat of tariffs and rising geopolitical tension, the outlook for dealmaking in 2026 is strong. Balanced against the fog of uncertainty, which the industry is navigating, is the stark reality of the coming patent cliff and the fact that the big pharma companies have access to $1.619 trillion with which to replenish their pipelines.
Four years after they were first mooted, the finishing line is in sight for new U.K. clinical regulations, which will come into force on April 28. In the first major update since 2004, about 20% of lower-risk studies are expected to be approved by a fast track, and the Medicines and Healthcare products Regulatory Agency will introduce a 14-day assessment route for phase I healthy volunteer trials, amongst other measures to streamline approvals.
Corxel Pharmaceuticals Ltd. completed a $287 million series D round to advance its lead compound, an oral small-molecule GLP-1 receptor agonist, CX-11, for obese and overweight patients.
The U.S. NIH may be weathering the budget storm thanks to bipartisan congressional support, but another squall line is forming on the horizon over politicization of the research agency.
The structurally similar cytokines IL-2 and IL-15, and their shared beta subunit CD122, are keeping developers busy across a range of indications. Though some scientific confusion has plagued the space historically, drug candidates have drawn deals and Wall Street interest aplenty. Amgen Inc., Novartis AG, and Incyte Corp. are among those who’ve made their interest known.
After only three $1 billion-plus biopharma deals in November, December saw 14 blockbuster deals worth a total of $21.92 billion, including four deals worth more than $2 billion.
As China emerges as a critical commercial market and a source of global innovation, the newly released 2026 edition of Clarivate’s Drugs to Watch report highlights six drugs to watch in the China market for the year ahead.