The EMA had its second busiest year ever in 2025, approving 104 drugs, of which 38 had a new active substance. Sixteen of these are for treating rare diseases, and four are advanced therapy medicinal products.
Biopharma financing values have shown quarterly volatility over the past decade, with surges often concentrated in specific quarters rather than evenly distributed throughout the year. The pandemic era marked a clear inflection point, and more recently, financing patterns have normalized with outsized quarters driving annual totals. In 2025, total financings accelerated as the year progressed, rising from $13.12 billion in the first quarter (Q1) to $18.92 billion in Q3 to a peak of $33.16 billion in Q4, the strongest quarter since early 2024.
U.S. President Donald Trump unveiled his “Great Healthcare Plan” Jan. 15, an initiative he said would slash prescription drug prices, maximize price transparency in the health care system and hold big insurance companies accountable.
For decades, scientists have searched for a mechanistic link between viral infection and multiple sclerosis (MS). Insights from three studies recently published in Cell bring that connection into sharper focus. By tracing how the immune system responds to Epstein-Barr virus (EBV) – and how those responses can misfire against the brain – researchers are beginning to uncover a compelling biological explanation for MS.
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Argenx, Biogen, Bio Usawa, Fortress, Pharmaessentia, Sentynl, Solid.