编者按：截至2025年12月19日，FDA旗下的药物评价和研究中心（CDER）已经批准了44款创新药，其中“first-in-class”药物占比约55%，展现了新药开发领域的不断创新。小分子药物占比66%，并有多款新药靶向全新蛋白靶点。4款多肽和核酸类药物获批上市，显示这些治疗模式成为新药开发的重要方向之一。作为创新的赋能者、客户信赖 ...

Zycubo received breakthrough therapy, fast track, rare paediatric disease and orphan drug designations from the FDA.

The FDA has approved Zycubo (copper histidinate) injection as the first and only treatment of Menkes disease in pediatric ...

The U.S. Food and Drug Administration approved Fortress Biotech and Indian drugmaker Zydus Lifesciences' drug for children ...

阿舍·穆拉德 | 撰文潘展 | 编译最近，Nature Reviews Drug ...

The FDA approved a prescription at-home brain neuromodulation therapy as an adjunctive depression treatment for adults, maker ...

Under the FDA Commissioner's National Priority Voucher Program unveiled in June, U.S. Food ​and Drug Administration chief ...

An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...

Dr. Soon-Shiong is hopeful the Saudi Arabian FDA's approval of his cancer therapy drug, Anktiva, will lead to widespread ...

The FDA previously rejected Zycubo for Menkes disease in October last year, citing issues with the drug’s manufacturing ...

More than half a dozen major drugmakers are participating in the Trump administration's speedier review program for new ...

Clene is scheduled to meet with the FDA in the coming months to discuss new data for CNM-Au8, its experimental oral therapy ...