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.

1st Biotherapeutics Inc. announced the closing of a ₩31.7 billion series D funding round Jan. 26 to advance its lead phase I oncology asset, FB-849, and portfolio of candidates for neurodegenerative diseases.

After the U.S. House passed a package of spending bills Jan. 22 to fund several agencies and departments, including Health and Human Services, through fiscal 2026, the Senate was expected to quickly follow suit to ensure that no part of the federal government would shut down when the current continuing resolution expires Jan. 30. That was before a confrontation with Immigration and Customs Enforcement in Minnesota turned deadly over the weekend.

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.

In a lawsuit that’s been bouncing through the courts for years, the U.S. Court of Appeals for the District of Columbia once again cleared the way for several biopharma and medical device companies to potentially be held liable, under the Anti-Terrorism Act, for terrorist attacks against hundreds of Americans in Iraq.

After a roller coaster of a year for Duchenne muscular dystrophy (DMD) gene therapy Elevidys (delandistrogene moxeparvovec), Sarepta Therapeutics Inc. looks to focus on the efficacy narrative in 2026, starting with newly unveiled three-year data showing durable efficacy across all key motor function assessments for treated DMD patients vs. external controls.