The new year 2026 will bring new challenges for the pharmaceutical and biotechnology industry as well as policymakers[1]. Atlas Venture's Bruce Booth predicts a surge in IPOs in the biotech sector after two years of stagnation[1][3]. Improved performance of biotech stocks and renewed investor interest in venture investments[1][3] is expected. AstraZeneca announced that the new combination drug Imfinzi did not prolong the lives of lung cancer patients and licensed the KRAS inhibitor from China for $100 million[1]. In the first quarter of 2026, the top-line results of Alumis' ONWARD phase 3 study of envudeucitinib in moderate-to-severe plaque psoriasis and the interim results of Arrowhead Pharmaceuticals' phase 1 studies of ARO-INHBE and ARO-ALK7 in obesity[2] are to watch for in the first quarter of 2026. The FDA is on track to approve approximately 50-52 new drugs this year, down slightly from the average of 60 approvals over the past five to six years[4].