Mayo Clinic’s Chelsee Jensen, PharmD, discusses FDA policy changes, biosimilar development hurdles, denosumab lessons, and ...
On Dec 19, 2025, the US Food and Drug Administration (FDA) announced a major milestone by qualifying total hip bone mineral density (BMD), assessed by dual-energy X-ray absorptiometry, as a surrogate ...
Illustration of New Drug Application paperwork surrounded by pills, vials, and DNA. The US Food and Drug Administration approved 46 new molecular entities in 2025. Credit: C&EN/Shutterstock The year ...
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Scientists map a road to fairer, more inclusive drug development
A new analysis of drug trials used to approve medicines in the United States shows how far modern medicine still has to go to serve everyone fairly. Only 6% of the clinical trials that backed new ...
“Companies should really sit down and say, could I meet these points?” Hogan Lovells partner Lynn Mehler said. “How do I follow the larger concept at play here, which is FDA willingness to be ...
In the realm of modern medicine, RNA-based therapies have emerged as a promising avenue, with significant advancements in metabolic diseases, oncology, and preventive vaccines. A recent article ...
“Just 10 years ago, there was virtually no biopharmaceutical industry in China. But now, almost all global big pharma companies are seeking new drug candidates there.” Brad Loncar, CEO of U.S. asset ...
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